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

Phase 1

Completed

• Conditions: Lymphoma, B-Cell; T-Cell Lymphoma
• Interventions: Drug: RP6530

• Registration Number: NCT02017613
• Lead Sponsor: Rhizen Pharmaceuticals SA

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-23
• Status Verified: 2016-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	RP6530	RP6530 administered orally

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical response following administration of RP6530	8 weeks	Overall response rate (ORR) and duration of response (DOR).

Trial Locations

Locations (3)

Rhizen Trial Site; 🇫🇷 Paris, France

Rhizen Trial Site 1; 🇮🇹 Milano, Italy

Rhizen Trial Site 2; 🇮🇹 Milano, Italy