A Phase I/II Study of GX15-070MS in Untreated CLL
- Registration Number
- NCT00600964
- Lead Sponsor
- Gemin X
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GX15-070MS GX15-070MS GX15-070MS at various doses and schedules
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
University of CA- San Diego
🇺🇸La Jolla, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Milton S Hershey Medical Center Penn State Cancer Institute
🇺🇸Hershey, Pennsylvania, United States
UT MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
University of CA- San Diego🇺🇸La Jolla, California, United States