A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer - Full Text View

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, August 2008

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
	Local Institution	Not yet recruiting
	Rochester, Minnesota, United States, 55905
	Contact: 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
First Received:	April 29, 2008
Last Updated:	September 26, 2008
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 October 10, 2008