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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 (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00886782
First received: April 22, 2009
Last updated: September 23, 2015
Last verified: September 2015
  Purpose
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 Intervention Phase
Advanced Solid Cancers Metastatic Cancer Drug: Cdc7-inhibitor Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 11
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  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: 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
  More Information

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
Study First Received: April 22, 2009
Last Updated: September 23, 2015

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

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

ClinicalTrials.gov processed this record on August 21, 2017