Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00798252

Purpose

To determine safety and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors

Condition	Intervention	Phase
Advanced Cancer	Drug: Capecitabine Drug: Doxorubicin Drug: Ixabepilone Drug: Docetaxel Drug: Paclitaxel Drug: Brivanib alaninate	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Paclitaxel Docetaxel Capecitabine Ixabepilone BMS540215 Brivanib alaninate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To determine safety and the maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors [ Time Frame: Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To describe the anti-tumor activity of brivanib alaninate combination with the different chemotherapeutic regimens: capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel [ Time Frame: Every 21 days ] [ Designated as safety issue: Yes ]
To assess the effect each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel on the pharmacokinetics of BMS-540215 (active moiety of brivanib pro-drug) at the MTD [ Time Frame: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2 ] [ Designated as safety issue: Yes ]
To assess the effect of brivanib alaninate on the pharmacokinetics each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel chemotherapy regimens at the MTD [ Time Frame: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	189
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A (Capecitabine + Brivanib alaninate)	Drug: Capecitabine Tablets, Oral, Dose escalation to a MTD from a starting dose of 850 mg/m², twice a day (BID) x 14d per cycle, until disease progression Other Name: Xleoda® Drug: Brivanib alaninate Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression Other Name: BMS-540215
Experimental: Arm B (Doxorubicin + Brivanib alaninate)	Drug: Doxorubicin IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression Other Name: Adriamycin® Drug: Brivanib alaninate Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression Other Name: BMS-540215
Experimental: Arm C (Ixabepilone + Brivanib alaninate)	Drug: Ixabepilone IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression Other Names: IXEMPRA® BMS-247550 Drug: Brivanib alaninate Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression Other Name: BMS-540215
Experimental: Arm D (Docetaxel + Brivanib alaninate)	Drug: Docetaxel IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression Other Name: Taxotere® Drug: Brivanib alaninate Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression Other Name: BMS-540215
Experimental: Arm E (Paclitaxel + Brivanib alaninate)	Drug: Paclitaxel IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression Other Name: Taxol® Drug: Brivanib alaninate Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression Other Name: BMS-540215

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologic/cytologic diagnosis of advanced or metastatic solid tumors
Life expectancy >= 3 months
Able to swallow tablets/capsules

Exclusion Criteria:

Pregnant or breastfeeding women
No more than 4 previous chemotherapy regimens in the advanced or metastatic setting (excluding prior adjuvant or hormonal / immuno / biologic antibody therapies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798252

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, California
Usc/Norris Comprehensive Cancer Center	Recruiting
Los Angeles, California, United States, 90033
Contact: Anthony El-Khoueiry, Site 005
United States, Massachusetts
Dana-Farber Cancer Inst	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Geoffrey Shapiro, Site 002
United States, Michigan
Wayne State University	Recruiting
Detroit, Michigan, United States, 48201
Contact: Patricia Mucci Lorusso, Site 001
Canada, Alberta
Local Institution	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 004
Canada, Ontario
Local Institution	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 003

Sponsors and Collaborators

Bristol-Myers Squibb

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:	NCT00798252 History of Changes
Other Study ID Numbers:	CA182-030, 2007-005097-31
Study First Received:	November 25, 2008
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Bristol-Myers Squibb:

metastatic, chemotherapy combination

Additional relevant MeSH terms:

Neoplasms
Docetaxel
Capecitabine
Antineoplastic Agents
Doxorubicin
Paclitaxel
Therapeutic Uses
Pharmacologic Actions

Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on February 09, 2012