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

NCT00798252 | Completed Phase 1

• 2 other identifiers: CA182-0302007-005097-31
• Study Type: interventional
• Target: 111
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Advanced Cancer

Keywords

metastatic, chemotherapy combination

Outcome Measures

Primary Outcomes (1)

• 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

  Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached

Secondary Outcomes (3)

• To describe the anti-tumor activity of brivanib alaninate combination with the different chemotherapeutic regimens: capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel

  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

  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

  Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2

Study Arms (5)

Arm A (Capecitabine + Brivanib alaninate)

EXPERIMENTAL

Drug: Capecitabine; Drug: Brivanib alaninate

Arm B (Doxorubicin + Brivanib alaninate)

EXPERIMENTAL

Drug: Doxorubicin; Drug: Brivanib alaninate

Arm C (Ixabepilone + Brivanib alaninate)

EXPERIMENTAL

Drug: Ixabepilone; Drug: Brivanib alaninate

Arm D (Docetaxel + Brivanib alaninate)

EXPERIMENTAL

Drug: Docetaxel; Drug: Brivanib alaninate

Arm E (Paclitaxel + Brivanib alaninate)

EXPERIMENTAL

Drug: Paclitaxel; Drug: Brivanib alaninate

Interventions

Capecitabine DRUG

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

Also known as: Xleoda®

Arm A (Capecitabine + Brivanib alaninate)

Doxorubicin DRUG

IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression

Also known as: Adriamycin®

Arm B (Doxorubicin + Brivanib alaninate)

Ixabepilone DRUG

IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression

Also known as: IXEMPRA®, BMS-247550

Arm C (Ixabepilone + Brivanib alaninate)

Docetaxel DRUG

IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression

Also known as: Taxotere®

Arm D (Docetaxel + Brivanib alaninate)

Paclitaxel DRUG

IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression

Also known as: Taxol®

Arm E (Paclitaxel + Brivanib alaninate)

Brivanib alaninate DRUG

Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression

Also known as: BMS-540215

Arm A (Capecitabine + Brivanib alaninate); Arm B (Doxorubicin + Brivanib alaninate); Arm C (Ixabepilone + Brivanib alaninate); Arm D (Docetaxel + Brivanib alaninate); Arm E (Paclitaxel + Brivanib alaninate)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (5)

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Local Institution

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Capecitabine; Doxorubicin; ixabepilone; Docetaxel; Paclitaxel; brivanib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: March 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

CA (2); US (3)