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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 15, 2008

Last Updated Date

January 24, 2008

Start Date ^†

September 2004

Current Primary Outcome Measures ^†

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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00600964 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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)

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Chronic Lymphocytic Leukemia

Intervention ^†

Drug: GX15-070MS

Study Arms / Comparison Groups

Experimental: GX15-070MS at various doses and schedules

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

January 2006

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600964

Responsible Party

Jean Viallet, MD, Gemin X, Inc.

Secondary IDs ^††

Study Sponsor ^†

Gemin X

Collaborators ^††

Investigators ^†

Study Director:

Jean Viallet, MD

Gemin X, Inc.

Information Provided By

Gemin X

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.