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

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ClinicalTrials.gov Identifier: NCT00546247
Recruitment Status : Terminated
First Posted : October 18, 2007
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Epofolate Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : January 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00546247     History of Changes
Other Study ID Numbers: CA190-001
First Posted: October 18, 2007    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015