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

Bristol-Myers Squibb (BMS) logo

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)

39 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Epofolate

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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