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

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00546247
First received: October 17, 2007
Last updated: January 24, 2011
Last verified: July 2010
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 1)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ]

Enrollment: 26
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Other Name: BMS-753493

  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

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 22057
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Netherlands
Local Institution
Rotterdam, Netherlands, 3075 EA
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  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: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00546247     History of Changes
Other Study ID Numbers: CA190-001
Study First Received: October 17, 2007
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 22, 2013