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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

NCT ID: NCT01659047

Last Updated: 2012-09-07

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WITHDRAWN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

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

Keywords

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Chronic Lymphocytic Leukemia CLL CAL-101 Ofatumumab

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

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Langdon Miller, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Countries

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United States

Other Identifiers

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GS-US-312-0120

Identifier Type: -

Identifier Source: org_study_id