Overview

This trial is active, not recruiting.

Conditions chronic lymphocytic leukemia, mantle cell lymphoma, diffuse large b-cell lymphoma, indolent non-hodgkin's lymphoma
Treatments entospletinib, idelalisib
Phase phase 2
Target PI3K
Sponsor Gilead Sciences
Start date June 2013
End date April 2014
Trial size 66 participants
Trial identifier NCT01796470, GS-US-339-0103

Summary

This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of entospletinib and idelalisib. Participants will be enrolled who have one of the following hematological tumor types: chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma [MZL]).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Entospletinib plus idelalisib at one of 4 dose combinations (400 mg/100 mg; 600 mg/100 mg; 800 mg/100 mg; 800 mg/150 mg). After discontinuation of entospletinib+idelalisib combination therapy, and following a washout period, participants may continue to receive entospletinib 400 mg monotherapy.
entospletinib GS-9973
Entospletinib tablets administered orally twice daily
idelalisib GS-1101
Idelalisib tablets administered orally twice daily

Primary Outcomes

Measure
Objective response rate
time frame: up to 48 weeks

Secondary Outcomes

Measure
Safety and tolerability
time frame: up to 48 weeks
Maximum tolerated dose level
time frame: up to 48 weeks
Progression-free survival
time frame: up to 48 weeks
Duration of response
time frame: up to 48 weeks
Time to response
time frame: up to 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of B-cell iNHL, DLBCL, MCL, or CLL as documented by medical records and with histology based on criteria established by the World Health Organization - For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®; GS-1101); subjects with malignancies being studied in these protocols must have failed screening and be registered as a screen failure in the respective idelalisib protocol - Prior treatment for lymphoid malignancy - Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy - Discontinuation of all therapy for the treatment of cancer ≥ 3 weeks before the start of study drug - All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug - Karnofsky performance status of ≥ 60 - Life expectancy of at least 3 months Exclusion Criteria: - Known histological transformation from iNHL or CLL to an aggressive form of NHL (ie, Richter transformation) - Known active central nervous system or leptomeningeal lymphoma - Presence of known intermediate- or high-grade myelodysplastic syndrome - Current therapy with agents that reduce gastric acidity, including but not limited to antacids, H2 inhibitors, and proton pump inhibitors - Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug - Ongoing liver injury - Ongoing or recent hepatic encephalopathy - Ongoing drug-induced pneumonitis - Ongoing inflammatory bowel disease - Ongoing alcohol or drug addiction - Pregnancy or breastfeeding - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation - Ongoing immunosuppressive therapy - Concurrent participation in an investigational drug trial with therapeutic intent

Additional Information

Official title A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Combination With Idelalisib in Subjects With Relapsed or Refractory Hematologic Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.