A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

This study has been terminated.
Sponsor:
Collaborator:
Exelixis
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00886782
First received: April 22, 2009
Last updated: January 24, 2011
Last verified: October 2010

April 22, 2009
January 24, 2011
May 2009
August 2010   (final data collection date for primary outcome measure)
Determine maximum tolerated dose and anti-tumor activity of BMS-863233 when administered to subjects with advanced and/or Metastatic solid tumors [ Time Frame: Every 28 days until the MTD is reached ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00886782 on ClinicalTrials.gov Archive Site
Determine the safety, pharmacokinetics and anti-tumor activity of BMS-863233 when administered to subjects with advanced and/or solid cancers [ Time Frame: Every 28 days until the MTD is reached ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors
A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors

The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Solid Cancers
  • Metastatic Cancer
Drug: Cdc7-inhibitor
Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months
Other Names:
  • BMS-863233
  • XL413
Experimental: Cdc7-inhibitor
Intervention: Drug: Cdc7-inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
August 2010
August 2010   (final data collection date for primary outcome measure)

Phase 1 Inclusion Criteria:

  • Subjects with advanced and/or metastatic solid tumors who are either refractory to or have relapsed from standard therapies, or for whom a standard therapy does not exist.
  • ECOG performance status ≤ 2
  • Accessible for treatment, PK sample collection and required study follow-up
  • Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 2.5 x ULN

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease
  • Exposure to any investigational agent within 4 weeks of study drug administration
  • Subjects a history of gastrointestinal disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France
 
NCT00886782
CA198-002, EUDRACT Number: 2009-010572-20
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Exelixis
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP