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

Sponsor:	Bristol-Myers Squibb
Collaborator:	Exelixis
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00886782

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	May 2009
Estimated Study Completion Date:	August 2010
Estimated 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
Genders Eligible for Study:	Both
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

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form 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

No publications provided

Responsible Party:	Study Director, 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:	January 24, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada European Union: European Medicines Agency

Keywords provided by Bristol-Myers Squibb:

Advanced and/or Metastatic solid cancers

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012