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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798252
First Posted: November 26, 2008
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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

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 ]

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 ]
  • 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 ]
  • 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 ]

Enrollment: 111
Study Start Date: March 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798252


Locations
United States, California
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00798252     History of Changes
Other Study ID Numbers: CA182-030
2007-005097-31 ( EudraCT Number )
First Submitted: November 25, 2008
First Posted: November 26, 2008
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Bristol-Myers Squibb:
metastatic, chemotherapy combination

Additional relevant MeSH terms:
Neoplasms
Paclitaxel
Docetaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Capecitabine
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors