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)
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia
Both
Chronic Lymphocytic Leukemia
Trial Information
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)
Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending
doses.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks
Outcome Time Frame:
14 days
Safety Issue:
Yes
Principal Investigator
Jean Viallet, MD
Investigator Role:
Study Director
Investigator Affiliation:
Gemin X, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
GX004
NCT ID:
NCT00600964
Start Date:
September 2004
Completion Date:
January 2006
Related Keywords:
- Chronic Lymphocytic Leukemia
- CLL
- obatoclax
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
| University of CA- San Diego | La Jolla, California 92093 |
| Milton S Hershey Medical Center Penn State Cancer Institute | Hershey, Pennsylvania 17033 |
