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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary: 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.
Sponsor: Rhizen Pharmaceuticals SA

Current Primary Outcome: Safety of RP6530 [ Time Frame: 28 days ]

Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0


Original Primary Outcome:

  • Maximum tolerated dose (MTD) of RP6530 [ Time Frame: 28 days ]
    Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
  • Blood level of RP6530 [ Time Frame: 28 days ]
    Peak Plasma Concentration (Cmax) of RP6530


Current Secondary Outcome:

  • Overall response rate (ORR) with RP6530 [ Time Frame: 8 months ]
    No of patients with partial and complete response
  • Duration of Response (DOR) with RP6530 [ Time Frame: 24 months ]
    The time period from the response achieved in patient until the disease progression.
  • Peak Plasma Concentration (Cmax) [ Time Frame: 28 days ]
    Peak Plasma Concentration (Cmax) of RP6530


Original Secondary Outcome:

  • Overall response rate (ORR) with RP6530 [ Time Frame: 8 months ]
    No of patients with partial and complete response
  • Duration of Response (DOR) with RP6530 [ Time Frame: 24 months ]
    The time period from the response achieved in patient until the disease progression.


Information By: Rhizen Pharmaceuticals SA

Dates:
Date Received: September 3, 2015
Date Started: September 2015
Date Completion: December 2017
Last Updated: April 7, 2017
Last Verified: September 2016