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

Sponsor
Rhizen Pharmaceuticals SA (Industry)
Overall Status
Completed
CT.gov ID
NCT02017613
Collaborator
(none)
35
Enrollment
3
Locations
1
Arm
30
Duration (Months)
11.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2013
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm

RP6530 administered orally

Drug: RP6530
Escalating doses starting at 25 mg BID
Other Names:
  • PI3k Delta/ Gamma inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530 [28 days]

      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

    1. Clinical response following administration of RP6530 [8 weeks]

      Overall response rate (ORR) and duration of response (DOR).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rhizen Trial Site Paris France
    2 Rhizen Trial Site 1 Milano Italy
    3 Rhizen Trial Site 2 Milano Italy

    Sponsors and Collaborators

    • Rhizen Pharmaceuticals SA

    Investigators

    • Study Chair: Andrés JM Ferreri, MD, Ospedale San Raffaele s.r.l.
    • Principal Investigator: Carmelo Carlo-stella, MD, Humanitas Clinical and Research Centre
    • Principal Investigator: Richard Delarue, MD, Hopital Necker-Enfants Malades

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rhizen Pharmaceuticals SA
    ClinicalTrials.gov Identifier:
    NCT02017613
    Other Study ID Numbers:
    • RP6530-1301
    • 2013-003769-32
    First Posted:
    Dec 23, 2013
    Last Update Posted:
    Jun 24, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Rhizen Pharmaceuticals SA
    CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Tenalisib

    Study Results

    No Results Posted as of Jun 24, 2016