Back to resultsA 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
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GS-1101
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, CLL, CAL-101, Ofatumumab
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GS-1101
Arm Description
GS-1101 (oral; 150 mg BID)
Outcomes
Primary Outcome Measures
Progression-free survival
Patient Well-Being
Health-related quality-of-life questionnaire
Disease-related Biomarkers
Pharmacokinetics
Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin)
Incidence of Adverse Events
Health Resource Utilization
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01659047
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Chronic Lymphocytic Leukemia, CLL, CAL-101, Ofatumumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GS-1101
Arm Type
Experimental
Arm Description
GS-1101 (oral; 150 mg BID)
Intervention Type
Drug
Intervention Name(s)
GS-1101
Other Intervention Name(s)
CAL-101
Intervention Description
150 mg taken twice daily by mouth
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
18 mon
Title
Patient Well-Being
Description
Health-related quality-of-life questionnaire
Time Frame
18 months
Title
Disease-related Biomarkers
Time Frame
18 months
Title
Pharmacokinetics
Description
Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin)
Time Frame
6 months
Title
Incidence of Adverse Events
Time Frame
18 months
Title
Health Resource Utilization
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Langdon Miller, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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