A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma

Related Clinical Trial
Neoadjuvant Toripalimab Combined With Chemotherapy in the Treatment of Malignant Pleural Mesothelioma PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma Olaparib in Patients With HRD Malignant Mesothelioma αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors Intravenous Magnesium in Patients Receiving Cisplatin SAKK 17/18 (ORIGIN) MPM & NSCLC >1st Line Gemci & Atezo Ph II Transitions Project High Resolution Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study 18F-FSPG PET/CT for Cancer Patients on Therapy Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso Molecular Analysis of Thoracic Malignancies A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies Oral TrkA Inhibitor VMD-928 for Treatment of Advanced Adult Solid Tumors or Lymphoma Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion Pulmonary Interstitial Lymphography in Early Stage Lung Cancer Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer Amatuximab for High Mesothelin Cancers αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies First-in-human Study of S-588210 (S-488210+S-488211) Study of the Glutaminase Inhibitor CB-839 in Solid Tumors Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer Rapid Autopsy and Procurement of Cancer Tissue Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs Mithramycin for Lung, Esophagus, and Other Chest Cancers APG-2449 in Patients With Advanced Solid Tumors CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD) Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study. Rehabilitation by Effort for Patients With Advanced Bronchial Cancer A Study of LY3023414 in Participants With Advanced Cancer Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas Study of FAK (Defactinib) and PD-1 (Pembrolizumab) Inhibition in Advanced Solid Malignancies (FAK-PD1) A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers A Study of MORAb-009 in Subjects With Pancreatic Cancer, Mesothelioma, or Certain Types of Ovarian or Lung Cancer Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin Study of the Combination of Tivantinib Plus Pemetrexed and Carboplatin Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen Dose Individualization of Pemetrexed – IMPROVE-III Dose Individualization of Pemetrexed – IMPROVE-II Dose Individualization of Pemetrexed – IMPROVE-I Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura Radical Pleurectomy/Decortication (PD) and Intensity Modulated Radiotherapy (IMRT) uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma. Gefitinib in Treating Patients With Malignant Mesothelioma DENdritic Cell Immunotherapy for Mesothelioma Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or Mesothelioma Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma. Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma Early Diagnosis of Lung Cancer and Mesothelioma in Prior Asbestos Workers Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma A Phase 1 Dose Escalation Study of VS-5584 Administered in Combination With VS-6063, in Subjects With Relapsed Malignant Mesothelioma Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma Sorafenib in Previously Treated Malignant Mesothelioma A Phase II Study of the Association of Glivec® Plus Gemzar® in Patients With Unresectable, Refractory, Malignant Mesothelioma Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107 Capecitabine in Treating Patients With Malignant Mesothelioma A Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma Olaparib in People With Malignant Mesothelioma CheckpOiNt Blockade For Inhibition of Relapsed Mesothelioma IP3R Modulation by Cancer Genes in Mesothelioma Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung Cisplatin With Alimta or Gemcitabine in Long Infusion for Mesothelioma Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma A Double Blind, Placebo Controlled, Randomized Phase II Study Evaluating Gemcitabine With or Without Ramucirumab , for II Line Treatment MPM Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed Dendritic Cell-based Immunotherapy Combined With Low-dose Cyclophosphamide in Patients With Malignant Mesothelioma Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment SU5416 in Treating Patients With Malignant Mesothelioma Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma Autologous Redirected RNA Meso-CIR T Cells Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma Mesothelioma Avastin Plus Pemetrexed-cisplatin Study Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma MesomiR 1: A Phase I Study of TargomiRs as 2nd or 3rd Line Treatment for Patients With Recurrent MPM and NSCLC Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With NSCLC or MPM Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage MPM Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma Tomotherapy Treatment for Mesothelioma Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma Mesothelioma and Radical Surgery 2 Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery Isolated Thoracic Perfusion (ITP-F) for MPM Dendritic Cells Loaded With Allogeneous Cell Lysate in Mesothelioma Patients An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery Tumor Cell Vaccines With ISCOMATRIX Adjuvant and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma Serum Biomarkers in Diagnosis of Mesothelioma Short Neoadjuvant Hemithoracic IMRT for MPM Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma Nivolumab in Patients With Recurrent Malignant Mesothelioma Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma Four Versus Six Cycles of Pemetrexed/Platinum for MPM A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma Nintedanib (BIBF 1120) in Mesothelioma Surgery for Mesothelioma After Radiation Therapy “SMART” for Resectable Malignant Pleural Mesothelioma Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced MPM Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma Vinorelbine in Mesothelioma Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma Cisplatin, Interferon Alfa, Surgery, and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma S0509 – AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma Staging Procedures to Diagnose Malignant Pleural Mesothelioma Observational Prospective Analysis of Biological Characteristics of Mesothelioma Patients Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Mesothelioma Pazopanib in Treating Patients With Malignant Pleural Mesothelioma Intrapleural Gene Transfer for Pleural Mesothelioma Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma Thromboelastography During Surgery for Malignant Pleural Mesothelioma Evaluation of CRS-207 With Pembrolizumab in Previously Treated Malignant Pleural Mesothelioma (MPM) Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM) An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17) Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma Combination Gene Transfer and Chemotherapy Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma Bortezomib in Treating Patients With Malignant Pleural Mesothelioma Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM) A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma A Phase II Study of Single-agent DOVitinib in Advanced Malignant PlEural Mesothelioma Which Has Progressed Following Prior Platinum-Antifolate Chemotherapy Combination Chemotherapy With or Without Surgery and Chemoradiotherapy in Treating Patients With Malignant Pleural Mesothelioma The IMmunotherapy Pleural 5-ALA PDT Intrapleural Cryotherapy for Malignant Pleural Mesothelioma Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma. Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed Dendritic Cell-based Immunotherapy in Mesothelioma MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Do Your Genes Put You at a Higher Risk of Developing Mesothelioma Trimodality Therapy for Malignant Pleural Mesothelioma Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma Ganetespib With Platinum, in Patients With Malignant Pleural Mesothelioma Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma Intrapleural Photodynamic Therapy in a Multimodal Treatment for Patients With Malignant Pleural Mesothelioma Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma Dasatinib in Resectable Malignant Pleural Mesothelioma Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma A Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma ATREUS – Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM) Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma Pembrolizumab + Defactinib In Pleural Mesothelioma Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma Vascularity Impact on the Treatment Outcome in Malignant Pleural Mesothelioma(VITMPM) Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma. Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma Response Evaluation in Malignant Pleural Mesothelioma Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

Brief Title

A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma

Official Title

A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma

Brief Summary

      This is a non-randomized open label multicentre Phase II trial to evaluate the response rate
      of PF03446962 in patients with advanced malignant pleural mesothelioma who have been
      previously treated with cytotoxic chemotherapy.
    

Detailed Description

      To assess the efficacy (response rate, complete and partial) of PF-03446962 given by IV
      infusion Day 1 of a 2 week cycle (14 days = 1 cycle) in patients with advanced malignant
      pleural mesothelioma and previously treated with cytotoxic therapy.

      To assess the toxicity, safety and tolerability of PF-03446962.

      To assess the duration of response or stable disease, stable disease rate, progression-free,
      median and overall survival rates.

      To collect tissue and blood for banking and correlative science evaluation.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response Rate

Secondary Outcome

 Amount and severity of adverse events

Condition

Malignant Pleural Mesothelioma

Intervention

PF-03446962

Study Arms / Comparison Groups

 PF-03446962
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

17

Start Date

November 30, 2011

Completion Date

February 13, 2015

Primary Completion Date

April 27, 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed malignant pleural
             mesothelioma.

          -  Patients must have advanced and/or metastatic disease, incurable by standard
             therapies.

          -  All patients must have a tumour block from their primary or metastatic tumour
             available and consent to release the block for correlative analyses.
             Centre/pathologist must have agreed to the submission of the specimens in both Stage I
             and II of accrual. For patients entered in Stage I of accrual, if no archival tissue
             is available, patient must undergo a biopsy prior to registration.

          -  All patients entered in Stage II of accrual must have an accessible tumour lesion
             (from primary or metastatic disease) for a fresh biopsy, which is formalin fixed and
             paraffin embedded. These patients must consent to this biopsy for entry on the trial.

          -  Presence of clinically and/or radiologically documented disease. At least one site of
             disease must be unidimensionally measurable as follows:

          -  Chest X-ray ≥ 20 mm CT scan (with slice thickness of ≤ 5 mm) ≥ 10 mm longest diameter
             Physical exam (using calipers) ≥ 10 mm Lymph nodes by CT scan ≥ 15 mm measured in
             short axis All radiology studies must be performed within 21 days prior to
             registration (Exception: Within 28 days if negative).

          -  Age ≥ 18 years.

          -  Patients must have a life expectancy of at least 12 weeks.

          -  ECOG performance status 0 or 1. Performance Status 2 patients are eligible, if, in the
             opinion of the investigator, they are suitable for inclusion in the study and are
             likely to be compliant with the study procedures (in particular the recommendations
             for supportive care and dose modification).

        Previous Therapy

        Cytotoxic Chemotherapy:

          -  Patients are eligible after first line cytotoxic chemotherapy has failed

          -  Patients must have received one, but no more than one, combination chemotherapy
             regimen for advanced disease, which must have contained a platinum agent, and
             treatment failure must have been documented

             o Exchange of one chemotherapy agent for another within a combination chemotherapy
             regimen due to toxicity (and not due to progressive disease) is not considered a new
             regimen in the following circumstances

               -  Carboplatin is substituted for cisplatin due to nephrotoxicity or ototoxicity

               -  One agent in the combination regimen is changed due to hypersensitivity occurring
                  in the first cycle

          -  28 days must have elapsed since last chemotherapy treatment (at least 6 weeks for
             nitrosoureas or mitomycin C) and patient must have recovered from toxic effects.

        Other Anti-Cancer Therapy:

        • Patients may have received other non-cytotoxic investigational therapy; 28 days must have
        elapsed since last treatment, such as anti-angiogenic or growth factor antagonists.

        Radiation:

        Patients may have had prior radiation therapy. A minimum of 28 days must have elapsed
        between the end of radiotherapy and registration onto the study. Radiation must have
        involved < 30% of functioning bone marrow and there must be measurable disease outside the
        previously irradiated area (patients whose sole site of disease is in previously irradiated
        area are ineligible) unless there is evidence of progression or new lesions have been
        documented, in the irradiated field). [Exceptions may be made however for low dose
        palliative radiotherapy].

        Previous Surgery:

        Previous major surgery is permitted provided that it has been at least 28 days prior to
        patient registration and that wound healing has occurred.

        Laboratory requirements must be done within 7 days prior to registration) Hematology:
        Granulocytes (ANC) ≥1.5 x 109/L Platelets ≥100 x 109/L Chemistry: Bilirubin ≤ULN AST and
        ALT ≤2.5 x ULN Calcium ≤3 mmol /L INR ≤1.5 x ULN Serum creatinine ≤ULN Or Creatinine
        clearance ≥60 ml/min if creatinine is >ULN Creatinine clearance to be measured directly by
        24 hour urine sampling or as calculated by Cockcroft Formula:Females: GFR=1.04 x(140-age)x
        weight in kg serum creatinine in μmol/L; Males: GFR=1.23 x (140-age)x weight in kg serum
        creatinine in μmol/L

          -  Patient consent must be appropriately obtained in accordance with applicable local and
             regulatory requirements. Each patient must sign a consent form prior to registration
             in the trial to document their willingness to participate.

          -  Patients must be accessible for treatment, response assessment and follow-up. Patients
             registered on this trial must be treated and followed at the participating centre.
             This implies there must be reasonable geographical limits (for example: 1 ½ hour's
             driving distance) placed on patients being considered for this trial. Investigators
             must assure themselves the patients registered on this trial will be available for
             complete documentation of the treatment, response assessment, adverse events and
             follow up.

          -  In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working
             days of patient registration.

        Exclusion Criteria:

          -  Patients with a history of other malignancies, except: adequately treated non-melanoma
             skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
             curatively treated with no evidence of disease for ≥5 years.

          -  Patients with known brain metastases. (A head CT is not necessary to rule out brain
             metastases, unless there is clinical suspicion of CNS involvement). Patients with
             known brain metastases will be excluded from this trial due to their poor prognosis
             and their likelihood of developing progressive neurologic dysfunction that would
             confound the evaluation of neurologic and other adverse events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to PF-03446962.

          -  Patients receiving concurrent treatment with other anti-cancer therapy or other
             investigational anticancer agents.

          -  Patients with any of the following cardiovascular findings are to be excluded:

               -  QTc prolongation ( defined as a mean QTc interval with Bazetts correction equal
                  to or greater than 470 msec) in screening ECG or history of familial long QT
                  syndrome. An ECG must be done within 14 days prior to registration.

               -  Patients with resting BP consistently higher than, systolic > 150 mmHg and/or
                  diastolic > 100 mmHg (in the presence or absence of a stable dose of
                  anti-hypertensive medication) or poorly controlled hypertension, history of
                  labile hypertension or poor compliance with anti-hypertensive medication.

               -  Patients who have experienced untreated and/or uncontrolled cardiovascular
                  conditions and/or have symptomatic cardiac dysfunction (unstable angina,
                  congestive heart failure, myocardial infarction within the previous year or
                  cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd
                  degree atrioventricular conduction defects). Patients with a significant cardiac
                  history even if controlled, should have a LVEF > 50%.

          -  History of pulmonary embolism within the past 12 months; exceptions may be made for
             incidental pulmonary emboli found on routine scanning providing not within the past 6
             months.

          -  History of cerebrovascular accident (CVA) or transient ischemic attack within 12
             months prior to study entry.

          -  Patients with overt bleeding from any site (> 30 ml bleeding/episode) within 3 months
             of study entry are not eligible. No clinically relevant hemoptysis (> 5 ml fresh
             blood) within 4 weeks prior to study entry is permitted. Patients with only flecks of
             blood in sputum are permitted.

          -  Patients who require use of therapeutic doses of anticoagulants such as warfarin,
             heparin or low molecular weight heparin (except for low doses for prophylaxis). INR
             must be done within 7 days prior to registration.

          -  Patients with bowel obstruction or any condition or gastrointestinal tract disease
             that would increase the risk for gastrointestinal perforation, including abdominal
             fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of
             treatment.

          -  Patients with serious illness or medical condition which would not permit the patient
             to be managed according to the protocol including, but not limited to:

               -  History of significant neurologic or psychiatric disorder which would impair the
                  ability to obtain consent or limit compliance with study requirements;

               -  Active uncontrolled infection;

               -  Any other medical conditions that might be aggravated by treatment;

               -  Serious or non-healing wound, ulcer, or bone fracture.

          -  The following are exclusions for enrollment on the study:

               -  Pregnant or lactating women. (N.B.: All women of childbearing potential must have
                  a negative pregnancy test within 7 days prior to registration).

               -  Women must be post-menopausal, surgically sterile or use two reliable forms of
                  contraception while on study and for 6 months after discontinuing therapy. Men
                  must be surgically sterile or use a barrier method of contraception with
                  spermicide. Should a woman become pregnant or suspect she is pregnant while
                  participating in this study, she should inform her treating physician
                  immediately.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Quincy Chu, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01486368

Organization ID

I207


Responsible Party

Sponsor

Study Sponsor

NCIC Clinical Trials Group

Collaborators

 Pfizer

Study Sponsor

Quincy Chu, Study Chair, Cross Cancer Institute, Edmonton, AB Canada


Verification Date

April 2020