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A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, January 2009
Sponsors and Collaborators: Bristol-Myers Squibb
Exelixis
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00670189
  Purpose

The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule


Condition Intervention Phase
Cancer
Drug: BMS-833923 (XL139)
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1 Multiple Ascending Dose Study of BMS-833923 in Subjects With Advanced or Metastatic Solid Tumors

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety assessments including physical findings, laboratory tests, and radiographic assessments to establish a recommended Phase 2 dose range and schedule [ Time Frame: collected throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine exposure levels of BMS-833923 in the body and to evaluate the effect of BMS-833923 on tumor cell growth [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A1: Experimental Drug: BMS-833923 (XL139)
Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced or metastatic cancer (excluding cancer in the blood) or uncontrolled basal cell nevoid syndrome or sporadic basal cell carcinoma
  • Primary or metastatic tumor site accessible for biopsy
  • Ability to swallow capsules

Exclusion Criteria:

  • Uncontrolled brain metastasis
  • Significant cardiovascular disease
  • Inadequate blood counts
  • Inadequate liver, kidney or lung function
  • Gastrointestinal disease within last 3 months
  • Infection with HIV, Hepatitis B or Hepatitis C or exposure to attenuated active immunizations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670189

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, Arizona
Local Institution Not yet recruiting
Scottsdale, Arizona, United States, 85259
Contact: Site 004            
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Steven Alberts, Site 003            
United States, Texas
Southwest Texas Addiction Research And Tech (Start) Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Kyriakos Papadopoulos, Site 002     210-593-5250        
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 001            
Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA194-002
Study First Received: April 29, 2008
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00670189  
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Study placed in the following topic categories:
Neoplasm Metastasis

ClinicalTrials.gov processed this record on January 16, 2009