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A Phase I/II Study of GX15-070MS in Untreated CLL

This study has been completed.
Sponsor:
Information provided by:
Gemin X
ClinicalTrials.gov Identifier:
NCT00600964
First received: January 15, 2008
Last updated: September 15, 2010
Last verified: September 2010
History of Changes

January 15, 2008
September 15, 2010
September 2004
January 2006   (final data collection date for primary 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 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00600964 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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)

This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.

Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Drug: GX15-070MS
    A 60-minute or 3-hour IV infusion every 2-3 weeks.
    Other Name: Obatoclax
  • Drug: GX15-070MS
    GX15-070MS at various doses and schedules
    Other Name: Obatoclax
Experimental: GX15-070MS
GX15-070MS at various doses and schedules
Interventions:
  • Drug: GX15-070MS
  • Drug: GX15-070MS
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. Epub 2008 Oct 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00600964
GX004
No
Jean Viallet, MD, Gemin X, Inc.
Gemin X
Not Provided
Study Director: Jean Viallet, MD Gemin X, Inc.
Gemin X
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP