Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 386 · 10 trials · 22 indications
Paclitaxel PK parameters with and without the co-administration of AMG 386.
| Arm | Type | Description |
|---|---|---|
| AMG 386 | EXPERIMENTAL | Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW |
| AMG 386 Placebo | PLACEBO_COMPARATOR | Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW |
| 15mg/ kg cohort | EXPERIMENTAL | AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule. |
| 10 mg/kg cohort | EXPERIMENTAL | AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule. |
| 2 | PLACEBO_COMPARATOR | AMG 386 placebo QW, FOLFIRI Q2W |
| 1 | ACTIVE_COMPARATOR | Arm 1 : AMG 386 10 mg/kg QW, FOLFIRI Q2W |
| Arm A | EXPERIMENTAL | Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 10 mg/kg IV QW |
| Arm B | EXPERIMENTAL | Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 3 mg/kg IV QW |
| Arm C | ACTIVE_COMPARATOR | Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 placebo |
| A | EXPERIMENTAL | Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 10 mg/kg IV QW |
| D | EXPERIMENTAL | Paclitaxel 90 mg/m² IV QW (3 on/1 off) + Open Label AMG 386 10 mg/kg IV QW |
| B | EXPERIMENTAL | Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 3 mg/kg IV QW |
| C | ACTIVE_COMPARATOR | Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 placebo IV QW |
| AMG 386 15mg/kg and paclitaxel 80mg/m2 | EXPERIMENTAL | - |
| Group 1 | EXPERIMENTAL | Cancer subjects with normal renal function. |
| Group 3 | EXPERIMENTAL | Cancer subjects with moderate renal impairment. |
| Group 4 | EXPERIMENTAL | Cancer subjects with severe renal impairment. |
| Group 2 | EXPERIMENTAL | Cancer subjects with mild renal impairment. |
| Name | Type | Description |
|---|---|---|
| AMG 386 | DRUG | Weekly Intravenous (IV) AMG 386 15 mg/kg |
| AMG 386 Placebo | DRUG | Weekly Intravenous (IV) placebo 15 mg/kg |
| Paclitaxel | DRUG | Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off) |
| Sorafenib | DRUG | Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort \& 10mg/kg cohort |
| FOLFIRI | DRUG | Administration of FOLFIRI chemotherapy will commence on day 1 of each dosing week following the administration of AMG 386. FOLFIRI Q2W regimen: irinotecan 180 mg/m2 IV over 90 (+-15) minutes on Day 1, leucovorin 400 mg/m2 IV over 2 hrs on Day 1, 5 FU 400mg/m2 IV bolus, followed by 2400 mg/m2 continuous IV infusion over 46 hrs +- 2 hours. FOLFIRI will be administered until disease progression, FOLFIRI intolerability, death, or study withdrawal by the subject, investigator, or sponsor, whichever occurs earliest. |
| Bevacizumab | DRUG | Bevacizumab 10mg/kg IV Q2W |
| AMG 386 placebo IV | DRUG | AMG 386 placebo IV |
| Pemetrexed | DRUG | Pemetrexed 500 mg/m2 |
| Carboplatin | DRUG | Carboplatin AUC 6 |
| AMG 386 + Paclitaxel | DRUG | 15 mg/kg IV (in the vein) of AMG 386 weekly + 80 mg/m\^2 IV (in the vein) 3 weeks on/1 week off, optional beginning week 6 until progression, unacceptable toxicity, or withdrawal of consent. |
Inclusion Criteria: * Female 18 years of age or older at the time the written informed consent is obtained * Gynecologic Oncology Group (GOG) Performance Status of 0 or 1 * Life expectancy \>= 3 months (per investigator opinion) * Histologically or cytologically documented invasive epithelial ovari...
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.