NCT00207025

Brief Summary

The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.

Trial Health

40
At Risk

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
2 countries

3 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

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

March 2, 2010

Status Verified

July 1, 2008

Enrollment Period

2.3 years

First QC Date

September 12, 2005

Last Update Submit

February 27, 2010

Conditions

Tumors

Keywords

Patients with advanced solid tumors

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

Secondary Outcomes (1)

  • PK, preliminary evidence of antitumor activity

Interventions

BMS-275183DRUG

Eligibility Criteria

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

You may qualify if:

  • Non-hematologic malignancy that has progressed or no standard therapy is known
  • Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • No more than 3 prior chemotherapy regimens in advanced/metastatic setting
  • Absolute neutrophil count \>=1,500/mm3 and platelets \>=100,000/mm3
  • Bilirubin \<=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase \<=2.5 x ULN
  • Serum creatinine \<=1.5 x ULN
  • Men and women \>=18 years
  • Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study

You may not qualify if:

  • WOCBP and men not using adequate method of birth control
  • WOCBP who are pregnant or breastfeeding
  • Prior radiation \>=25% of bone marrow containing skeleton
  • Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder
  • Neuropathy
  • Active brain metastases
  • Inability to swallow capsules
  • History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube
  • Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution

Detroit, Michigan, United States

Location

Local Institution

Pittsburgh, Pennsylvania, United States

Location

Local Institution

Brussels, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

BMS-275183

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

October 1, 2004

Primary Completion

February 1, 2007

Last Updated

March 2, 2010

Record last verified: 2008-07

Locations

US(2)BE(1)