drugset / Trial / NCT02624986

A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants

NCT02624986

Phase 1/2 Terminated 25 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a open-label, multicenter, non-randomized, study to evaluate the safety, efficacy, and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with R/R FL and rituximab in combination with idasanutlin in R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase 2 dose (RP2D) for idasanutlin in combination with obinutuzumab for FL and in combination with rituximab for DLBCL. The expansion phase is designed to further assess the safety and efficacy of obinutuzumab in combination with idasanutlin at the RP2D with the selected regimen in participants with R/R FL and of rituximab in combination with idasanutlin at the RP2D in participants with R/R DLBCL.

Timeline

Start
2015-12-23
Primary completion
2019-05-20
Completion
2019-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Idasanutlin Small molecule 100 mg Oral
Subject Idasanutlin Small molecule 150 mg Oral
Subject Idasanutlin Small molecule 200 mg Oral
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications