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

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ClinicalTrials.gov Identifier: NCT00207025
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Tumors Drug: BMS-275183 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies
Study Start Date : October 2004
Primary Completion Date : February 2007
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Safety and Tolerability

Secondary Outcome Measures :
  1. PK, preliminary evidence of antitumor activity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00207025     History of Changes
Other Study ID Numbers: CA165-012
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: July 2008

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