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

Gilead Sciences

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Chronic Lymphocytic Leukemia; Lymphoma, Non-Hodgkin

Treatments: Drug: Idelalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090414

101-99

Details and patient eligibility

About

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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of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.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible
• Women of childbearing potential must have a negative pregnancy test to be eligible
• Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol

Key Exclusion Criteria:

• Patients who are unwilling or unable to comply with the protocol are not eligible

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

202 participants in 1 patient group

Idelalisib

Experimental group

Description:

Participants will receive up to 350 mg of idelalisib twice daily until disease progression or unacceptable toxicity.

Treatment:

Drug: Idelalisib