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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00550017

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 2)

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:	December 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 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 through 4 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 Criteria:

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: NCT00550017

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, Indiana
Local Institution	Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site 004
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lynn Hartmann, Site 001
Canada, Ontario
Local Institution	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 003
United Kingdom, Tyne And Wear
Local Institution	Recruiting
Newcastle-Upon-Tyne, Tyne And Wear, United Kingdom, NE4 6BE
Contact: Site 002

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA190-002
Study First Received:	October 24, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00550017
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 15, 2009