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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Epofolate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550017

CA190-002

Details and patient eligibility

About

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)

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Epofolate