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

Primary Purpose

Lymphoma, B-Cell, T-Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RP6530
Sponsored by
Rhizen Pharmaceuticals SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rhizen Trial Site
  • Rhizen Trial Site 1
  • Rhizen Trial Site 2

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

RP6530 administered orally

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530
To access maximum tolerated dose by clinical laboratory assessments, adverse events and dose limiting toxicities. PK parameter AUC, Cmax, tmax, t1/2 will be determined.

Secondary Outcome Measures

Clinical response following administration of RP6530
Overall response rate (ORR) and duration of response (DOR).

Full Information

First Posted
November 26, 2013
Last Updated
June 23, 2016
Sponsor
Rhizen Pharmaceuticals SA
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1. Study Identification

Unique Protocol Identification Number
NCT02017613
Brief Title
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies
Acronym
PI3K
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhizen Pharmaceuticals SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell, T-Cell Lymphoma
Keywords
CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
RP6530 administered orally
Intervention Type
Drug
Intervention Name(s)
RP6530
Other Intervention Name(s)
PI3k Delta/ Gamma inhibitor
Intervention Description
Escalating doses starting at 25 mg BID
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530
Description
To access maximum tolerated dose by clinical laboratory assessments, adverse events and dose limiting toxicities. PK parameter AUC, Cmax, tmax, t1/2 will be determined.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Clinical response following administration of RP6530
Description
Overall response rate (ORR) and duration of response (DOR).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés JM Ferreri, MD
Organizational Affiliation
Ospedale San Raffaele s.r.l.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carmelo Carlo-stella, MD
Organizational Affiliation
Humanitas Clinical and Research Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Delarue, MD
Organizational Affiliation
Hopital Necker-Enfants Malades
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhizen Trial Site
City
Paris
Country
France
Facility Name
Rhizen Trial Site 1
City
Milano
Country
Italy
Facility Name
Rhizen Trial Site 2
City
Milano
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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