Trial | NCT02017613  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rp6530 ...

  • Study Participants

    35
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.
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 Started
Nov 30
2013
Primary Completion
May 31
2016
Study Completion
May 31
2016
Last Update
Jun 24
2016
Estimate

Drug RP6530

Escalating doses starting at 25 mg BID

  • Other names: PI3k Delta/ Gamma inhibitor

Single arm Experimental

RP6530 administered orally

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.
No Results Posted