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

This study is not yet open for participant recruitment.

Verified by Bristol-Myers Squibb, April 2009

First Received: April 22, 2009 No Changes Posted

Sponsors and Collaborators:	Bristol-Myers Squibb 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 I Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ] [ 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:	June 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cdc7-inhibitor: Experimental	Drug: Cdc7-inhibitor Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months

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

Sponsors and Collaborators

Bristol-Myers Squibb

Exelixis

Investigators

Study Director:

Bristol-Myers Squibb

More Information

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA198-002, EUDRACT Number: 2009-010572-20
Study First Received:	April 22, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00886782 History of Changes
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

Study placed in the following topic categories:

Neoplasm Metastasis

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on May 06, 2009