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

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ClinicalTrials.gov Identifier: NCT00886782
Recruitment Status : Terminated
First Posted : April 23, 2009
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Cancers Metastatic Cancer Drug: Cdc7-inhibitor Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Cdc7-inhibitor 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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00886782


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
France
Local Institution
Villejuif Cedex, France, 94800
Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00886782     History of Changes
Other Study ID Numbers: CA198-002
EUDRACT Number: 2009-010572-20
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015

Keywords provided by Bristol-Myers Squibb:
Advanced and/or Metastatic solid cancers

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes