Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)

NCT ID: NCT02242045

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2017-10-17

Brief Summary

The primary objective of this study is to evaluate the 28-day safety and tolerability, and to determine the pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or refractory indolent B-cell non-Hodgkin lymphomas (iNHL) or chronic lymphocytic leukemia (CLL).

Conditions

Chronic Lymphocytic Leukemia; Indolent Non-Hodgkin Lymphoma; Follicular Lymphoma; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia); Marginal Zone Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Idelalisib

Participants with iNHL or CLL will receive idelalisib until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.

Group Type: EXPERIMENTAL

Idelalisib

Intervention Type: DRUG

150 mg tablet(s) administered orally twice daily

Interventions

Idelalisib

150 mg tablet(s) administered orally twice daily

Intervention Type: DRUG

Other Intervention Names

Zydelig®; GS-1101; CAL-101

Eligibility Criteria

Inclusion Criteria

• Participants with mature B-cell malignancies of iNHL including follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, and CLL 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 participants 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Aichi, , Japan

Miyagi, , Japan

Tokyo, , Japan

Countries

Japan

References

Kinoshita T, Fukuhara N, Nagai H, Izutsu K, Kobayashi Y, et al. Phase 1b and Pharmacokinetic Study of Idelalisib in Japanese Patients with Relapsed or Refractory (R/R) Indolent B-Cell Non-Hodgkin Lymphoma (iNHL) or Chronic Lymphocytic Leukemia (CLL) [Abstract 85914]. Blood 2015;126:5089

Reference Type: RESULT

Fukuhara N, Kinoshita T, Yamamoto K, Nagai H, Izutsu K, Yamamoto G, Bhargava P, Rajakumaraswamy N, Humeniuk R, Mathias A, Xing G, Fukui M, Tobinai K. Phase 1b study to investigate the safety and tolerability of idelalisib in Japanese patients with relapsed/refractory follicular lymphoma and chronic lymphocytic leukemia. Jpn J Clin Oncol. 2020 Dec 16;50(12):1395-1402. doi: 10.1093/jjco/hyaa153.

Reference Type: RESULT

PMID: 32856068 (View on PubMed)

Other Identifiers

GS-US-313-1380

Identifier Type: -

Identifier Source: org_study_id