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

NCT00798252 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2015-07-07

No results posted yet for this study

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

Interventions

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

DRUG

Doxorubicin

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

DRUG

Ixabepilone

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

DRUG

Docetaxel

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

DRUG

Paclitaxel

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

DRUG

Brivanib alaninate

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00798252 on ClinicalTrials.gov