NCT00546247

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).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

2.2 years

First QC Date

October 17, 2007

Last Update Submit

September 23, 2015

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Drug: Epofolate

Interventions

EpofolateDRUG

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

Also known as: BMS-753493
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known brain metastases
  • Severe nerve damage
  • Significant cardiovascular disease
  • Inadequate blood counts
  • Inadequate liver or kidney function
  • Inadequate thyroid function or uncontrolled thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 22057, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Local Institution

Rotterdam, 3075 EA, Netherlands

Location

Related Links

MeSH Terms

Interventions

BMS-753493

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 18, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

NL(1)US(3)