A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia

Gilead Sciences

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: GS-1101

Study type: Interventional

Funder types: Industry

Identifiers

NCT01659047

GS-US-312-0120

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control

Full description

This is a Phase 2, multicenter, single-arm, controlled, clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia.

This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101 therapy.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participation in Study GS-US-312-0119
• Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312 0119.
• Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL.
• The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

GS-1101

Experimental group

Description:

GS-1101 (oral; 150 mg BID)

Treatment:

Drug: GS-1101