Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 386/kg, Paclitaxel and Trastuzumab · 1 trial · 10 indications
| Arm | Type | Description |
|---|---|---|
| Cohort A1 | EXPERIMENTAL | - |
| Cohort A3 | EXPERIMENTAL | - |
| Cohort B1 | EXPERIMENTAL | - |
| Cohort B3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMG 386 30 mg/kg, Paclitaxel and Trastuzumab | DRUG | AMG 386 30 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W |
| AMG 386 30 mg/kg, Capecitabine and Lapatinib | DRUG | AMG 386 30 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD |
| AMG 386 10 mgkg, Paclitaxel and Trastuzumab | DRUG | AMG 386 10 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W |
| AMG 386 10 mg/kg, Capecitabine and Lapatinib | DRUG | AMG 386 10 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD |
Inclusion Criteria: * histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease not amenable to any local treatment with curative intent. * HER2-positive by FISH, CISH, or IHC 3+ * ECOG performance status 0 or 1 * Left ventricular ejection f...
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AMG 386 is an investigational oncology drug being studied for advanced renal cell carcinoma, advanced solid tumors, carcinoma, gastrointestinal cancer, fallopian tube cancer, and locally recurrent and metastatic breast cancer. It is in Phase 2 clinical development and is not yet approved by the FDA.
AMG 386 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is an investigational small molecule in Phase 2 clinical development for multiple oncology indications.
AMG 386 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed, including a Phase 2 study in advanced renal cell carcinoma.
AMG 386 has been studied in several completed clinical trials, including NCT00467025, a Phase 2 study in advanced renal cell carcinoma; NCT01331941, a pharmacokinetic study in advanced solid tumors and renal impairment; NCT01666977, a Phase 1b/2 trial in non-small cell lung cancer; and NCT01992341, a drug-drug interaction study with paclitaxel.
AMG 386 is also known as trebananib. It is an investigational oncology drug being developed by Amgen Inc. for multiple cancer types, including advanced renal cell carcinoma and advanced solid tumors.