Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies

Learn more about:
Related Clinical Trial
A Phase 1, Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma. A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas AMG 319 Lymphoid Malignancy FIH Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) PD-1 Knockout EBV-CTLs for Advanced Stage Epstein-Barr Virus (EBV) Associated Malignancies Tandem Auto-Allo Transplant for Lymphoma Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies Study of Infusion of Blood Cells (Lymphocytes) to Stimulate the Immune System to Fight Leukemia/Lymphoma Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL) Study of AZD5991 in Relapsed or Refractory Haematologic Malignancies. p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies A Phase II Study Of Imtox-25 In Adults With Refractory/Relapsed Cd25 Positive Adult T Cell Leukemia/Lymphoma Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas CD4CAR for CD4+ Leukemia and Lymphoma Pembrolizumab for T/NK-cell lymphomasNK-cell Lymphomas Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma A Study for Patients With Non-Hodgkin’s Lymphomas High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma Allo-HSCT as First-line Consolidation in High-risk PTCL A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell Lymphoma Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas An Open Label, International, Multi-centre, Phase I/IIa Study of Lenalidomide (Revlimid) and Romidepsin (Istodax) for Relapsed /Refractory Hodgkin Lymphoma, Mature T-cell Lymphoma and Multiple Myeloma. (RId Study) A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low ( T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients A-dmDT390-bisFv(UCHT1) Immunotoxin Therapy for Patients With Cutaneous T-Cell Lymphoma (CTCL) Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL) Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL) ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas Phase I Dose-finding and Preliminary Efficacy Study of the Istodax® in Combination With Doxil® for the Treatment of Adults With Relapsed or Refractory Cutaneous T-cell Lymphoma Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-cell Lymphoma Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas Helical Irradiation of Total Skin (HITS) for T Cell Lymphoma Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL) CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia A Multicenter Clinical Trial of Daratumumab in Combination With Gemcitabine, Dexamethasone and Cisplatin in Patients With Relapsed/Refractory CD38 Positive PTCL-NOS, Angioimmunoblastic T-cell Lymphoma AITL and Other Nodal Lymphomas of T Follicular Helper Cells Origin Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma A Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin’s Lymphoma HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma Gemcitabine in NK/T Cell Lymphoma A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma Trial of Endostar Combined With CHOPT for T Cell Lymphoma Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma

Brief Title

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies

Official Title

A Phase I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K Delta/Gamma Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies

Brief Summary

      The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K
      delta/gamma inhibitor in patients with hematologic malignancies.
    

Detailed Description

      The Maximum tolerated dose (MTD) will be determined based on the safety, pharmacokinetic (PK)
      and efficacy data. Safety analyses include AE's, AE's related to the drug, SAE's, laboratory
      values, vitals/ ECG and dose limiting toxicity (DLT). PK include measurement of peak plasma
      concentration (Cmax), area under the plasma concentration versus the time curve (AUC), time
      of maximum concentration observed (Tmax). Efficacy analyses include overall response rate
      (ORR) and duration of response (DOR).
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530

Secondary Outcome

 Clinical response following administration of RP6530

Condition

Lymphoma, B-Cell

Intervention

RP6530

Study Arms / Comparison Groups

 Single arm
Description:  RP6530 administered orally

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

35

Start Date

November 2013

Completion Date

May 2016

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Refractory to or relapsed after at least 1 prior treatment line.

          -  ECOG performance status ≤2

          -  Patients must be ≥18 years of age

          -  Able to give a written informed consent.

        Exclusion Criteria:

          -  Any cancer therapy in the last 4 weeks or limited palliative radiation <2 weeks

          -  Patients with HBV, HCV or HIV infection

          -  Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic
             hematologic stem cell transplant within 12 months.

          -  Previous therapy with GS-1101 (CAL-101, idelalisib), IPI-145, TGR-1202 or any drug
             that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK
             Inhibitor (including Ibrutinib).

          -  Patients on immunosuppressive therapy including systemic corticosteroids.

          -  Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium
             or heparin, etc.).

          -  Patients with known history of liver disorders.

          -  Patients with uncontrolled Diabetes Type I or Type II

          -  Any severe and/or uncontrolled medical conditions or other conditions that could
             affect their participation in the study.

          -  Women who are pregnant or lactating.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andrés JM Ferreri, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02017613

Organization ID

RP6530-1301

Secondary IDs

2013-003769-32

Responsible Party

Sponsor

Study Sponsor

Rhizen Pharmaceuticals SA


Study Sponsor

Andrés JM Ferreri, MD, Study Chair, Ospedale San Raffaele s.r.l.


Verification Date

February 2016