Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer

Learn more about:
Related Clinical Trial
Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer Impact of Margin-accentuation IRE in Pancreatic Cancer Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer Gemcitabine, Bevacizumab, and Abdominal Radiation Therapy in Treating Patients With Localized Pancreatic Cancer Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer Combination of Radiation Therapy and Anti-PD-1 Antibody in Treating Patients With Pancreatic Cancer IORT Followed by CCRT or SBRT for Locally Advanced Pancreatic Cancer Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer Diet and Exercise After Pancreatic Cancer Compassionate Single Subject Use of FG-3019 (FibroGen) in Locally Advanced, Unresectable Pancreatic Cancer Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery Gem-TABS in Unresectable Pancreatic Carcinoma Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer Safety and Efficacy Study of Five-fraction Stereotactic Body Radiation Therapy to Locally Advanced Pancreatic Cancer Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer A Study of ABTL0812 in Pancreatic Cancer Immune Response After Pancreatic Cancer Treatment Combination of Stereotactic Body Radiation Therapy With S-1 for Treating Locally Advanced Pancreatic Cancer Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy Radiofrequency Probe for Management of Unresectable Bile Duct and Pancreatic Cancer Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer New Treatment Option for Pancreatic Cancer Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer Individual Patient Expanded Access IND of Hope Biosciences First Blood Relative Allogeneic Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Pancreatic Cancer Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic, Unresectable Pancreatic Cancer Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer Usefulness of Smartphone Application for Improving Nutritional Status of Pancreatic Cancer Patients Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer C-VISA BikDD: Liposome in Advanced Pancreatic Cancer Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer QUILT-3.080: NANT Pancreatic Cancer Vaccine Bevacizumab, Combination Chemotherapy, and Radiation Therapy in Treating Patients Undergoing Surgery For Locally Advanced Pancreatic Cancer A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer Oral Microbiome and Pancreatic Cancer IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants Genes as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer. BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer A Real-world Study of Albumin-bound Paclitaxel in the Treatment of Pancreatic Cancer Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Dasatinib in Treating Patients With Stage IV Pancreatic Cancer Study of Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy A Phase II Study of Combine Modality Therapy in Locally Advanced Pancreatic Cancer Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer Ghrelin Levels in Pancreatic Cancer Patients Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP) Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer A Phase II Study of Locally Advanced Pancreatic Cancer QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer Study of Ruxolitinib in Pancreatic Cancer Patients Gemcitabine/Cisplatin +/-Cetuximab in Patients With Locally Advanced or Metastatic EGFR-Positive Pancreatic Cancer Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Study of CellCept for Advanced Pancreatic Cancer Niraparib in Patients With Pancreatic Cancer Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer Longitudinal Pancreatic Cancer Study Safety and Efficiency of γδ T Cell Against Pancreatic Cancer A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer Autologous CARTmeso/19 Against Pancreatic Cancer Clinical Application of IRE Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer Depression, Cytokines and Pancreatic Cancer Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer A Dose Escalation Trial of SBRT After Induction Chemotherapy for Locally Advanced Pancreatic Cancer Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer Mutation of K-RAS, CDKN2A, SMAD4 and TP53 in Pancreatic Cancer: Role of Liquid Biopsy in Preoperative Diagnosis Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer Identification of Biomarkers for Early Detection of Pancreatic Cancer Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer Nano Drug Interventional Therapy Using Digital Subtraction Angiography(DSA) for Pancreatic Carcinoma Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer Gene Expression in Pancreatic Cancer Optical and Biochemical Biomarkers in Early Pancreatic Cancer Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer Valproic Acid With Chemoradiotherapy for Pancreatic Cancer Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer A Trial of Chemo & Radiation Therapy for Pancreatic Cancer Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer. The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome Ablation of Unresectable Locally Advanced Pancreatic Cancer With Irreversible Electroporation (IRE) System FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial Vaccine Treatment for Surgically Resected Pancreatic Cancer Characterizing the Pancreatic Cancer Proteome From Pancreatic Juice Quality of Life After Radiofrequency Ablation of Pancreatic Cancer Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC) Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery Pancreatic Cancer Collaborative Registry Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer Focused Ultrasound for the Treatment of Pancreatic Cancer – an International Registry Registry for Pancreatic Cancer Neoadjuvant/Adjuvant GVAX Pancreas Vaccine (With CY) With or Without Nivolumab and Urelumab Trial for Surgically Resectable Pancreatic Cancer Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer GI-4000 With Adoptive Transfer in Pancreatic Cancer Pancreatic Cancer Genetic Epidemiology (PACGENE) Study Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer Clinical Trial of Pancreatic Cancer in Stockholm. Phase I/II Study of LDE225 With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer Acquisition of Portal Venous CTCs and Exosomes From Patients With Pancreatic Cancer by EUS Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas Stool Testing for Pancreatic Cancer A Phase III Study of Pancreatic Cancer Pancreatic Cancer Genetics Integrated Positron Emission Tomography – Computed Tomography (PET-CT) in Patients With Pancreatic Cancer RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA) for Pancreatic Cancer Vaccine Study for Surgically Resected Pancreatic Cancer Low Dose Vaccine Study for Surgically Resected Pancreatic Cancer Studying Biomarkers in Patients With Pancreatic Cancer Prospective Phase I Study of GAX for Metastatic Pancreatic Cancer Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Brief Title

Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer

Official Title

Phase 1b Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer

Brief Summary

      To identify the maximally tolerated dose of ficlatuzumab when combined with nab-paclitaxel
      and gemcitabine in patients with previously untreated pancreatic cancer.
    

Detailed Description

      This research study is a Phase I dose-escalation clinical trial. It will test the safety and
      tolerability of an investigational drug ficlatuzumab when combined with Nab-paclitaxel and
      Gemcitabine, with the goal of determining the maximally tolerated dose of ficlatuzumab when
      combined with gemcitabine and nab-paclitaxel.

      Ficlatuzumab is a type of drug called a "monoclonal antibody." It is thought to work by
      targeting hepatocyte growth factor (HGF) which is a HGF-c-Met inhibitor. The activation of
      the receptor tyroside kinase c-Met via its ligand, HGF, mediates proliferation, motility, and
      differentiation in a variety of cancers including pancreatic cancer.

      Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer
      and meet all inclusion/exclusion criteria.

      Treatment consists of 4 week treatment cycles. Ficlatuzumab will be administered on day 1 and
      15 of each cycle. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15.

      Subjects continue in study until disease progression, adverse event/toxicity, death or either
      the subject or sponsor discontinues the study.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

The Maximum Tolerated Dose of ficlatuzumab when administered in combination with gemcitabine and nab-paclitaxel

Secondary Outcome

 The response rate in this population of patients.

Condition

Pancreatic Cancer

Intervention

Gemcitabine

Study Arms / Comparison Groups

 Ficlatuzumab + Gemcitabine and Nab-Paclitaxel
Description:  Ficlatuzumab will be administered intravenously days 1 and 15 of a 28 day cycle
Gemcitabine 1000 mg/m2 and Nab-Paclitaxel 125mg/m2 will be administered IV days 1, 8, and 15 of a 28 day cycle.
Dosage of Ficlatuzumab is determined by dose level to which the patient is assigned at time of enrollment.

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

26

Start Date

January 17, 2018

Completion Date

November 30, 2023

Primary Completion Date

November 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly
             differentiated pancreatic carcinoma that is metastatic to distant sites.

          -  Other histologies such as neuroendocrine and acinar cell carcinoma are excluded.

          -  No prior chemotherapy for locally advanced or metastatic pancreatic cancer.

          -  Patients are eligible if they received adjuvant treatment after surgical resection
             with single-agent gemcitabine or gemcitabine/capecitabine or 5-fluorouracil/leucovorin
             that was completed >12 months before enrollment. Similarly, adjuvant radiation +/-
             chemosensitization with 5-fluorouracil, capecitabine, or gemcitabine is allowed if
             completed >12 months before enrollment.

          -  Participants are required to have measurable disease (RECIST v1.1), defined as at
             least one lesion that can be accurately measured in at least one dimension (longest
             diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with
             spiral CT scan. See section 11 for the evaluation of measurable disease.

          -  Participants enrolled must have disease that is accessible for tumor biopsies and must
             agree to a pre-treatment tumor biopsy.

          -  Age ≥ 18 years. Because no dosing or adverse event data are currently available in
             participants <18 years of age, children are excluded from this study but will be
             eligible for future pediatric trials.

          -  ECOG performance status ≤2 (see Appendix A)

          -  Patients must have completed any major surgery or open biopsy ≥4 weeks from start of
             treatment.

          -  Participants must have adequate organ and marrow function as defined below:

               -  Absolute neutrophil count ≥1,500/mcL

               -  Platelets ≥100,000/mcL

               -  Total bilirubin ≤1.5 × institutional upper limit of normal

               -  AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal

               -  Creatinine ≤1.5 × institutional upper limit of normal OR

               -  Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels
                  above 1.5 × upper limit of normal.

          -  Negative serum pregnancy test for women of childbearing potential.

          -  The effects of ficlatuzumab on the developing human fetus are unknown. For this reason
             and because Hepatocyte Growth Factor inhibitors as well as other therapeutic agents
             used in this trial are known to be teratogenic, women of child-bearing potential and
             men must agree to use adequate contraception (hormonal or barrier method of birth
             control; abstinence) prior to study entry, for the duration of study participation and
             4 months after completion of ficlatuzumab administration.. Should a woman become
             pregnant or suspect she is pregnant while she or her partner is participating in this
             study, she should inform her treating physician immediately.

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Prior chemotherapy or any other investigational agents for the treatment of locally
             advanced or metastatic pancreatic cancer

          -  Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted
             therapy, immunotherapy, or biological agents.

          -  Participants with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.
             Screening for brain metastases with head imaging is not required.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ficlatuzumab or other agents used in study.

          -  History of prior or current synchronous malignancy, except:

               -  Malignancy that was treated with curative intent and for which there has been no
                  known active disease for >3 years prior to enrollment

               -  Curatively treated non-melanoma skin cancer, cervical cancer in situ, or
                  prostatic intraepithelial neoplasia, without evidence of prostate cancer

          -  Pre-existing, clinically significant peripheral neuropathy, defined as CTCAE grade 2
             or higher neurosensory or neuromotor toxicity, regardless of etiology

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, NYHA class III/IV congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements.

          -  Pregnant women are excluded from this study because ficlatuzumab is hepatocyte growth
             factor inhibitor agent with the potential for teratogenic or abortifacient effects.
             Because there is an unknown but potential risk for adverse events in nursing infants
             secondary to treatment of the mother with ficlatuzumab, breastfeeding should be
             discontinued if the mother is treated with ficlatuzumab. These potential risks may
             also apply to other agents used in this study
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kimberly Perez, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03316599

Organization ID

17-406


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 AVEO Pharmaceuticals, Inc.

Study Sponsor

Kimberly Perez, MD, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

January 2020