Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brivanib · 13 trials · 15 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 |
| 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 small molecule being studied for the treatment of solid tumors, hepatocellular carcinoma (HCC), liver cancer, and gastrointestinal cancers. It has been evaluated in clinical trials for these oncology indications, including advanced or metastatic solid tumors and hepatocellular carcinoma.
Brivanib is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company has sponsored clinical trials of Brivanib in patients with various cancers, including hepatocellular carcinoma and solid tumors.
Brivanib is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not approved by the FDA and remains in clinical development. All three completed trials were uncontrolled, meaning they did not include a comparison group.
Brivanib has been studied in three completed clinical trials. NCT00355238 was a Phase 2 study in hepatocellular carcinoma with 137 patients. NCT00390936 was a Phase 1 study in advanced solid tumors with 13 patients. NCT00437424 was a Phase 1 study in hepatocellular carcinoma with liver dysfunction, enrolling 24 patients.
Yes, Brivanib is also known as BMS-582664. Clinical trial records refer to the drug by both names, such as in the Phase 2 study of BMS-582664 in hepatocellular carcinoma and the Phase 1 study of Brivanib in liver cancer.