Advanced Cancer
Conditions
Keywords
metastatic, chemotherapy combination
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
Interventions
DRUGCapecitabine
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
DRUGDoxorubicin
IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression
DRUGIxabepilone
IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression
DRUGDocetaxel
IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression
DRUGPaclitaxel
IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression
Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed