NCT02567656

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Rhizen Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.

Detailed description

Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) and Duration of Response.

Conditions

• Lymphoma, T-Cell, Peripheral
• Lymphoma, T-Cell, Cutaneous

Interventions

Type	Name	Description
DRUG	RP6530	Tablet starting at 200 mg

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-03-01
• Completion: 2018-12-10
• First posted: 2015-10-05
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

8 sites across 1 country: United States