A Phase I/II Study of GX15-070MS in Untreated CLL
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)
1 other identifier
interventional
26
2 countries
5
Brief Summary
This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2004
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 15, 2008
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedMay 12, 2014
May 1, 2014
1.3 years
January 15, 2008
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks
14 days
Secondary Outcomes (1)
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.
14 days
Study Arms (1)
GX15-070MS
EXPERIMENTALGX15-070MS at various doses and schedules
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gemin Xlead
Study Sites (5)
University of CA- San Diego
La Jolla, California, 92093, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Milton S Hershey Medical Center Penn State Cancer Institute
Hershey, Pennsylvania, 17033, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
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.
PMID: 18931344RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean Viallet, MD
Gemin X, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 15, 2008
First Posted
January 25, 2008
Study Start
September 1, 2004
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
May 12, 2014
Record last verified: 2014-05