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

Rhizen Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Lymphoma, B-Cell

T-Cell Lymphoma

Treatments

Drug: RP6530

Study type

Interventional

Funder types

Industry

Identifiers

NCT02017613

2013-003769-32 (EudraCT Number)

RP6530-1301

Details and patient eligibility

About

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.

Full 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).

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.