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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014