Trial | NCT00600964  Report issue

Title

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)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    obatoclax ...

  • Study Participants

    26
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.
Study Started
Sep 30
2004
Primary Completion
Jan 31
2006
Study Completion
Jan 31
2006
Last Update
May 12
2014
Estimate

Drug GX15-070MS

A 60-minute or 3-hour IV infusion every 2-3 weeks.

  • Other names: Obatoclax

Drug GX15-070MS

GX15-070MS at various doses and schedules

  • Other names: Obatoclax

GX15-070MS Experimental

GX15-070MS at various doses and schedules

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
No Results Posted