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

Purpose

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

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: GX15-070MS	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

U.S. FDA Resources

Further study details as provided by Gemin X:

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 ]

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 ]

Enrollment:	26
Study Start Date:	September 2004
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GX15-070MS GX15-070MS at various doses and schedules	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

Detailed Description:

Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600964

Locations

United States, California
University of CA- San Diego
La Jolla, California, United States, 92093
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Pennsylvania
Milton S Hershey Medical Center Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Gemin X

Investigators

Study Director:

Jean Viallet, MD

Gemin X, Inc.

More Information

Publications:

Responsible Party:	Jean Viallet, MD, Gemin X, Inc.
ClinicalTrials.gov Identifier:	NCT00600964 History of Changes
Other Study ID Numbers:	GX004
Study First Received:	January 15, 2008
Last Updated:	September 15, 2010
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Gemin X:

CLL
obatoclax

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms

Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013