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 I

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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)

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
GX15-070MS: Experimental GX15-070MS at various doses and schedules	Drug: GX15-070MS A 60-minute or 3-hour IV infusion every 2-3 weeks. Drug: GX15-070MS GX15-070MS at various doses and schedules

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Responsible Party:	Gemin X, Inc. ( Jean Viallet, MD )
Study ID Numbers:	GX004
First Received:	January 15, 2008
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00600964
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Gemin X:

CLL

obatoclax

Study placed in the following topic categories:

Chronic lymphocytic leukemia

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoproliferative Disorders

Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Gemin X
Information provided by:	Gemin X
ClinicalTrials.gov Identifier:	NCT00600964