Overview

This trial is active, not recruiting.

Conditions chronic lymphocytic leukemia, indolent non-hodgkin lymphoma, follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma (with or without waldenstrom macroglobulinemia), marginal zone lymphoma
Treatments idelalisib, ofatumumab
Phase phase 1
Target PI3K
Sponsor Gilead Sciences
Start date October 2014
End date January 2017
Trial size 6 participants
Trial identifier NCT02242045, GS-US-313-1380

Summary

This study will evaluate the 28-day safety, tolerability, and pharmacokinetics (PK) of idelalisib with or without ofatumumab in Japanese participants with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Idelalisib cohort: Idelalisib 150 mg or 100 mg in participants with iNHL or CLL Idelalisib+ofatumumab cohort: Idelalisib 150 mg or 100 mg plus ofatumumab (300 mg (Week 0) then 1000 mg (Weeks 1, 2, 3, 4, 5, 6, 7, 11, 15, 19, and 23) in participants with CLL
idelalisib Zydelig®
Idelalisib tablet administered orally twice daily
ofatumumab Arzerra®
Ofatumumab administered intravenously according to dosing schedule

Primary Outcomes

Measure
Type, frequency, severity, timing, and relationship to idelalisib of adverse events (AEs), abnormal laboratory tests, and drug discontinuations due to AEs and serious adverse events (SAEs)
time frame: Up to 28 days
PK profile of idelalisib and its major metabolite GS-563117
time frame: Predose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, and 12.0 hours postdose on Days 1 and 29
Idelalisib trough and peak plasma concentrations
time frame: Predose and 1.5 hours postdose on Days 8, 15, and 22

Secondary Outcomes

Measure
Type, frequency, severity, timing, and relationship to idelalisib of AEs, abnormal laboratory tests, and drug discontinuations due to AEs and SAEs
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Subjects with mature B-cell malignancies of indolent non-Hodgkin lymphoma including follicular lymphoma, small lymphocytic lymphoma, lymphoplastic lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia by World Health Organization classification - Must have been born in Japan and must not have lived outside of Japan for > 1 year in the 5 years prior to Day 1. - Must be able to trace maternal and paternal ancestry of parents and grandparents as Japanese. - Must have been previously treated with at least 1 regimen for iNHL or CLL and currently require treatment. - Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of iNHL or CLL ≥ 4 weeks prior to Day 1 - Eastern Cooperative Oncology Group performance status of 0 or 1 - Required baseline laboratory data (within 4 weeks prior to Day 1) - A negative serum pregnancy test for female subjects of childbearing potential - Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. - In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individual's disease. Exclusion Criteria: - Known histological transformation to an aggressive histology - Known presence of myelodysplastic syndrome - History of iNHL or CLL with central nervous system involvement - Life expectancy < 120 days as per investigator assessment - History of a nonlymphoid malignancy with the following exceptions: - the malignancy has been in remission without treatment for ≥ 5 years prior to Day 1, or - carcinoma in situ of the cervix, or - adequately treated basal or squamous cell skin cancer or other localized nonmelanoma skin cancer, or - surgically treated low-grade prostate cancer, or - ductal carcinoma in situ of the breast treated with lumpectomy alone - On-going drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension - History or diagnosis of pneumonitis or interstitial lung disease. - On-going inflammatory bowel disease - Pregnancy or breastfeeding - History of prior allogeneic hematopoietic stem cell or solid organ transplantation - Concurrent participation in another therapeutic clinical trial - Prior or on-going clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results.

Additional Information

Official title A Phase 1b Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Subjects With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas or Chronic Lymphocytic Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.