A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 1)

This study is currently recruiting participants.

Verified by Bristol-Myers Squibb, January 2009

First Received: October 17, 2007 Last Updated: May 6, 2009 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00546247

Purpose

The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion).

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: Epofolate	Phase I Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:

A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subjects With Advanced Cancer (Schedule

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493) [ Time Frame: at the end of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493) [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	71
Study Start Date:	January 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Epofolate Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1, 4, 8 and 11 of a 21-day cycle, until the disease progresses

Eligibility

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

Criteria

Inclusion Criteria:

Advanced cancer, excluding cancer in the blood
Availability of 10 tumor tissue slides

Exclusion:

Known brain metastases
Severe nerve damage
Significant cardiovascular disease
Inadequate blood counts
Inadequate liver or kidney function
Inadequate thyroid function or uncontrolled thyroid disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546247

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, California
Local Institution	Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Site 006
United States, District of Columbia
Lombardi Comprehensive Cancer Center	Recruiting
Washington, District of Columbia, United States, 22057
Contact: John Marshall, Site 005 202-687-8921
United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Jason Konner, Site 002
Local Institution	Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Site 007
United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Lainie Martin, Site 001 215-214-3754
Netherlands
Local Institution	Recruiting
Rotterdam, Netherlands, 3075 EA
Contact: Site 003
Local Institution	Not yet recruiting
Rotterdam, Netherlands, 3075 EA
Contact: Site 004

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA190-001
Study First Received:	October 17, 2007
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00546247 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 07, 2009