NCT01090414

An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study

An Extension Study to Investigate the Safety and Durability of Clinical Activity of Idelalisib in Subjects With Hematologic Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.

Conditions

• Chronic Lymphocytic Leukemia
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Idelalisib	Idelalisib tablets or capsules administered orally

Timeline

• Start date: 2010-03-22
• Primary completion: 2018-06-18
• Completion: 2018-06-18
• First posted: 2010-03-22
• Last updated: 2019-08-28
• Results posted: 2019-08-28

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study