Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as brivanib (active), BMS-582664
Brivanib · 14 trials · 16 indications
The percent of participants who have not progressed or died prior to 6 months from the date of their first dose. Participants who have neither progressed nor died but had their last tumor assessment prior to 6 months will not be categorized as progression free and will not be included. Tumor response was measured by the IRRC using mWHO criteria. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline.
An Adverse Event (AE) is defined as any new untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Brivanib | ACTIVE_COMPARATOR | Adjuvant treatment with TACE Therapy |
| Brivanib Placebo | PLACEBO_COMPARATOR | Placebo adjuvant treatment with TACE Therapy |
| Sorafenib | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Arm: Brivanib | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | Japanese Population |
| Arm 1 - Phase 1 | ACTIVE_COMPARATOR | Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo |
| Arm 2 - Phase 2 | PLACEBO_COMPARATOR | Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| 6 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Brivanib | DRUG | Tablets, Oral, 200 mg, once daily, until disease progression or toxicity |
| Brivanib Placebo | OTHER | Tablets, Oral, 0 mg, once daily, until disease progression or toxicity |
| TACE Therapy | PROCEDURE | Trans-Arterial Chemo-Embolization Therapy |
| Placebo | DRUG | Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity |
| Sorafenib | DRUG | Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity |
| Best Supportive Care | PROCEDURE | Trans-Arterial Chemo-Embolization (TACE) Therapy |
| brivanib (active) | DRUG | Tablet, Oral, Brivanib 800 mg, once daily, until progression |
| 5-FU | DRUG | IV solution, IV bolus over 2-4 minutes, 400 mg/m², Every 14 days, Until disease progression/toxicity |
| Leucovorin | DRUG | IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity |
| Irinotecan | DRUG | IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity |
| Cetuximab | DRUG | IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression |
| Brivanib + Cetuximab | DRUG | Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks |
| Brivanab | DRUG | Tablets, Oral, 1000 mg, once daily, until disease progression |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Patients with diagnosis of hepatocellular carcinoma * Cirrhotic status of Child-Pugh Class A or B with a score of 7 * ECOG performance status of 0 or 1 * Adequate hematologi...
Brivanib is an investigational oral small molecule studied in oncology for advanced solid tumors, including hepatocellular carcinoma (liver cancer), advanced non-small cell lung cancer, colorectal cancer, and gastro-intestinal cancer. It has been evaluated both as a single agent and in combination with chemotherapy in clinical trials.
Brivanib targets the vascular endothelial growth factor receptors FLT1 (VEGFR1), FLT4 (VEGFR3), and KDR (VEGFR2), as well as the fibroblast growth factor receptors FGFR1, FGFR3, and FGFR4. It acts as an inhibitor of these receptor tyrosine kinases, blocking signaling pathways involved in tumor angiogenesis and growth.
Brivanib was developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company sponsored the clinical trial program evaluating brivanib in liver cancer and other advanced solid tumors.
Brivanib is in Phase 2 development overall, though it has been evaluated in Phase 3 trials for hepatocellular carcinoma. It is investigational and has not been approved by the FDA. All four registered trials of brivanib have been completed, and no trials are currently active.
Brivanib has been studied in four completed clinical trials: NCT01540461, a Phase 1 pharmacokinetics and safety study in Chinese subjects with hepatocellular carcinoma; NCT01046864, a Phase 1 combination study with 5-fluorouracil/leucovorin and FOLFIRI in gastro-intestinal cancer; NCT00908752, a Phase 3 TACE adjuvant HCC trial; and NCT00858871, a Phase 3 first-line HCC trial.