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

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: Epofolate

• Registration Number: NCT00550017
• Lead Sponsor: 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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Study First Posted: 2007-10-26
• Study Start: 2007-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Disposition First Submitted: 2011-06-21
• Status Verified: 2015-09
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Epofolate	-

Primary Outcome Measures

Name	Time	Method
To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493)	at the end of the study

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493)	every 21 days

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Local Institution; 🇬🇧 Newcastle Upon Tyne, Tyne And Wear, United Kingdom