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

Phase 2

Withdrawn

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: GS-1101

• Registration Number: NCT01659047
• Lead Sponsor: Gilead Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GS-1101	GS-1101	GS-1101 (oral; 150 mg BID)

Primary Outcome Measures

Name	Time	Method
Progression-free survival	18 mon
Patient Well-Being	18 months	Health-related quality-of-life questionnaire
Disease-related Biomarkers	18 months
Pharmacokinetics	6 months	Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin)
Incidence of Adverse Events	18 months
Health Resource Utilization	18 months