NCT02017613

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Rhizen Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lymphoma, B-Cell
• T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	RP6530	Escalating doses starting at 25 mg BID

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-12-23
• Last updated: 2016-06-24

Locations

3 sites across 2 countries: France, Italy