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

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)

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00546247

Enrollment

Registered

2007-10-18

Start date

2008-01-31

Completion date

2010-03-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

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).

Interventions

DRUGEpofolate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026