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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GS-1101

GS-1101 (oral; 150 mg BID)

Group Type EXPERIMENTAL

GS-1101

Intervention Type DRUG

150 mg taken twice daily by mouth

Interventions

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GS-1101

150 mg taken twice daily by mouth

Intervention Type DRUG

Other Intervention Names

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CAL-101

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No