Back to resultsA Phase I/II Study of GX15-070MS in Untreated CLL
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GX15-070MS
GX15-070MS
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, obatoclax
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed B-CLL
- Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1
- Age ≥18 years
- ECOG Performance Status ≤1
- Life expectancy of >8 weeks
Exclusion Criteria:
- Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy
- Patients with history of seizure disorders
- Pregnant women and women who are breast feeding
- HIV-positive patients receiving combination anti-retroviral therapy
Sites / Locations
- University of CA- San Diego
- Lombardi Cancer Center
- Milton S Hershey Medical Center Penn State Cancer Institute
- UT MD Anderson Cancer Center
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GX15-070MS
Arm Description
GX15-070MS at various doses and schedules
Outcomes
Primary Outcome Measures
Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks
Secondary Outcome Measures
Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00600964
Brief Title
A Phase I/II Study of GX15-070MS in Untreated CLL
Official Title
A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gemin X
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.
Detailed Description
Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
CLL, obatoclax
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GX15-070MS
Arm Type
Experimental
Arm Description
GX15-070MS at various doses and schedules
Intervention Type
Drug
Intervention Name(s)
GX15-070MS
Other Intervention Name(s)
Obatoclax
Intervention Description
A 60-minute or 3-hour IV infusion every 2-3 weeks.
Intervention Type
Drug
Intervention Name(s)
GX15-070MS
Other Intervention Name(s)
Obatoclax
Intervention Description
GX15-070MS at various doses and schedules
Primary Outcome Measure Information:
Title
Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed B-CLL
Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1
Age ≥18 years
ECOG Performance Status ≤1
Life expectancy of >8 weeks
Exclusion Criteria:
Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy
Patients with history of seizure disorders
Pregnant women and women who are breast feeding
HIV-positive patients receiving combination anti-retroviral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Viallet, MD
Organizational Affiliation
Gemin X, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of CA- San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Milton S Hershey Medical Center Penn State Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18931344
Citation
O'Brien SM, Claxton DF, Crump M, Faderl S, Kipps T, Keating MJ, Viallet J, Cheson BD. Phase I study of obatoclax mesylate (GX15-070), a small molecule pan-Bcl-2 family antagonist, in patients with advanced chronic lymphocytic leukemia. Blood. 2009 Jan 8;113(2):299-305. doi: 10.1182/blood-2008-02-137943. Epub 2008 Oct 17.
Results Reference
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A Phase I/II Study of GX15-070MS in Untreated CLL
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