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Also known as Motesanib Diphosphate
AMG 706 · 9 trials · 9 indications
| Arm | Type | Description |
|---|---|---|
| Arm One | EXPERIMENTAL | AMG 706 125mg, oral, once a day |
| Arm | OTHER | AMG 125 mg daily continuously |
| A | EXPERIMENTAL | - |
| Arm C | OTHER | Arm C - AMG 706 75 mg BID 5-days on and 2-days off |
| Arm B | OTHER | Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off |
| Arm A | OTHER | Arm A = AMG 706 125 mg PO daily continuously |
| B1 | EXPERIMENTAL | AMG 706 50 mg daily + Docetaxel (100 mg/m2 D1 every 21 days) |
| A4 | EXPERIMENTAL | 75 mg AMG 706 daily + Paclitaxel (90 mg/m2 on D1, D8 and D15 every 28 days) |
| A1 | EXPERIMENTAL | AMG 706 50 mg daily + Paclitaxel (90 mg/m2 D1, D8, D15 every 28 days) |
| B4 | EXPERIMENTAL | 75 mg AMG 706 daily + Docetaxel (100 mg/m2, D1 every 21 days) |
| B5 | EXPERIMENTAL | MTD of AMG 706 + Docetaxel (75mg/m2 D1 every 21 days) |
| B3 | EXPERIMENTAL | 100 mg AMG 706 daily + Docetaxel (100 mg/m2 on D1 every 21 days) |
| B2 | EXPERIMENTAL | AMG 706 125 mg daily + Docetaxel (100 mg/m2 D1 every 21 days) |
| A2 | EXPERIMENTAL | AMG 706 125 mg daily + paclitaxel 90 mg/m2 D1, D8, D15 every 28 days |
| A3 | EXPERIMENTAL | 100 mg AMG 706 daily + Paclitaxel (90 mg/m2 on D1, D8, and D15 every 28 days) |
| D | EXPERIMENTAL | 3 mg/kg AMG 386 IV (QW) / 125 mg AMG 706 PO (QD) |
| B | EXPERIMENTAL | 3 mg/kg AMG 386 IV (QW) / 75 mg AMG 706 PO (QD) |
| E | EXPERIMENTAL | 3 mg/kg AMG 386 IV (QW) / 400 mg sorafenib PO (BID) |
| H | EXPERIMENTAL | 10 mg/kg AMG 386 IV (QW) / 50 mg sunitinib PO (QD - 4 weeks on/2 weeks off) |
| G | EXPERIMENTAL | 3 mg/kg AMG 386 IV (QW) / 50 mg sunitinib PO (QD - 4 weeks on/2 weeks off) |
| C | EXPERIMENTAL | 10 mg/kg AMG 386 IV (QW) / 15 mg/kg bevacizumab IV (Q3W) |
| F | EXPERIMENTAL | 10 mg/kg AMG 386 IV (QW) / 400 mg sorafenib PO (BID) |
| AMG 706 50mg | ACTIVE_COMPARATOR | 50 mg, once daily. (Cohort 1) |
| AMG 706 75mg | ACTIVE_COMPARATOR | 75 mg, twice daily. (Cohort 2) |
| AMG 706 125mg | ACTIVE_COMPARATOR | 125 mg, once daily. (Cohort 3) |
| Part 2 AMG 706 (MTD) + FOLFOX-4 | EXPERIMENTAL | Maximum Tolerated Dose of AMG 706 established in Part 1b + FOLFOX-4 |
| 125 mg QD AMG 706 + FOLFOX-4 | EXPERIMENTAL | 125 mg QD AMG 706 + FOLFOX-4 |
| 50 mg QD AMG706 + panitumumab + FOLFIRI | EXPERIMENTAL | 50 mg QD AMG706 + panitumumab + FOLFIRI |
| Part 2 AMG 706 (MTD) + FOLFIRI | EXPERIMENTAL | Maximum Tolerated Dose of AMG 706 established in Part 1b + FOLFIRI |
| 100 mg QD AMG 706 + FOLFIRI | EXPERIMENTAL | 100 mg AMG 706 + FOLFIRI |
| 75 mg QD AMG 706 + panitumumab + FOLFOX-4 | EXPERIMENTAL | 75 mg QD AMG 706 + panitumumab + FOLFOX-4 |
| 75 mg BID AMG 706 + panitumumab + FOLFIRI | EXPERIMENTAL | 75 mg BID AMG 706 + panitumumab + FOLFIRI |
| 125 mg QD AMG 706 + panitumumab + FOLFIRI | EXPERIMENTAL | 125 mg QD AMG 706 + panitumumab + FOLFIRI |
| 125 mg QD AMG 706 + FOLFIRI | EXPERIMENTAL | 125 mg QD AMG 706 + FOLFIRI |
| 100 mg QD AMG 706 + panitumumab + FOLFIRI | EXPERIMENTAL | 100 mg QD AMG 706 + panitumumab + FOLFIRI |
| 75 mg QD AMG 706 + FOLFOX-4 | EXPERIMENTAL | 75 mg QD AMG 706 + FOLFOX-4 |
| 100 mg QD AMG 706 + FOLFOX-4 | EXPERIMENTAL | 100 mg QD AMG 706 + FOLFOX-4 |
| 50 mg QD AMG 706 + panitumumab + FOLFOX-4 | EXPERIMENTAL | 50 mg QD AMG 706 + panitumumab + FOLFOX-4 |
| 75 mg QD AMG706 + panitumumab + FOLFIRI | EXPERIMENTAL | 75 mg QD AMG706 + panitumumab + FOLFIRI |
| Name | Type | Description |
|---|---|---|
| AMG 706 | DRUG | AMG 706 125mg, oral, once a day |
| Docetaxel | DRUG | Subjects assigned to Arm B, cohorts will receive 75 or 100 mg/m2 of docetaxel (based on cohort assignment) on Day 1 repeated every 21 days (1 cycle). AMG 706 will be administered concurrently on Days 3-21 of Cycle 1, and Days 1-21 of Cycle 2 and beyond. |
| Paclitaxel | DRUG | Subjects assigned to Arm A will receive 90 mg/m2 of paclitaxel on Days 1, 8 and 15 repeated every 28 days (1 cycle). On Arm A, AMG 706 will be concurrently administered on Days 3-28 of Cycle 1, and Days 1-28 of Cycle 2 and beyond. |
| Sorafenib | DRUG | Sorafenib 400 mg PO (BID) |
| AMG 386 | DRUG | AMG 386 10 mg/kg IV (QW) |
| Sunitinib | DRUG | Sunitinib 50 mg PO (QD) |
| Bevacizumab | DRUG | Bevacizumab 15mg/kg IV Q3W |
| FOLFOX-4 | DRUG | The FOLFOX-4 regimen will be administered every 2 weeks as follows: Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed |
| Panitumumab (Part 1a only) | BIOLOGICAL | Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle. |
| FOLFIRI | DRUG | Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion. |
Inclusion Criteria: * Diagnosis of histological confirmed GIST * Had prior imatinib mesylate therapy * Has at least 1 measurable leasion by modified RECIST Exclusion Criteria: * Central nervous system tumor involvement requiring treatment * History of myocardial infraction * Uncontrolled hyperten...
AMG 706 is an investigational small molecule being studied for use in oncology. It has been evaluated in clinical trials for locally recurrent and metastatic breast cancer, advanced solid tumors, and other cancer types. As of the available data, it remains in clinical development and is not approved for any indication.
AMG 706 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen has sponsored multiple clinical trials of this investigational oncology drug.
AMG 706 is in Phase 2 clinical development. It has completed several Phase 1 trials, and the overall development program has reached Phase 2. The drug is investigational and has not been approved by regulatory authorities.
AMG 706 has been studied in completed trials including NCT00322400, a Phase 1b study in breast cancer; NCT00448786, a study of its effect on the gallbladder in solid tumors; NCT00861419, a combination study with other agents; and NCT01386866, a radiolabeled single-dose study.
AMG 706 is a distinct investigational drug developed by Amgen. It has been studied alone and in combination with agents such as paclitaxel, docetaxel, AMG 386, bevacizumab, sorafenib, and sunitinib, but it is not the same as those other medications.