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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00798252
First received: November 25, 2008
Last updated: August 11, 2014
Last verified: July 2014
  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
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:


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: September 2014
Estimated Primary Completion Date: September 2014 (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: 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: August 11, 2014
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
Liposomal doxorubicin
Docetaxel
Capecitabine
Antineoplastic Agents
Doxorubicin
Paclitaxel
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on August 19, 2014