A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207025
First received: September 12, 2005
Last updated: February 27, 2010
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Tumors
Drug: BMS-275183
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety and Tolerability

Secondary Outcome Measures:
  • PK, preliminary evidence of antitumor activity

Estimated Enrollment: 60
Study Start Date: October 2004
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207025

Locations
United States, Michigan
Local Institution
Detroit, Michigan, United States
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States
Belgium
Local Institution
Brussels, Belgium
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00207025     History of Changes
Other Study ID Numbers: CA165-012
Study First Received: September 12, 2005
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Patients with advanced solid tumors

ClinicalTrials.gov processed this record on April 15, 2014