Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 162 q 12 weeks · 1 trial · 3 indications
Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.
| Arm | Type | Description |
|---|---|---|
| IV Bisphosphonates q 4 weeks | ACTIVE_COMPARATOR | This is an open-label randomization to receive IV bisphosphonate (administered per package insert) every 4 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will receive AMG 162 180mg (SC) every 4 weeks. |
| 180 mg AMG 162 (SC) q 12 weeks | EXPERIMENTAL | This is an open-label randomization to receive 180 mg AMG 162 (SC) every 12 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 12 weeks. |
| 180 mg AMG 162 (SC) q 4 weeks | EXPERIMENTAL | This is an open-label randomization to receive 180 mg AMG 162 (SC) every 4 weeks during the treatment phase. If subject is enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| AMG 162 180 mg (SC) q 12 weeks | GENETIC | A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses. |
| IV Bisphosphonate q 4 weeks | DRUG | IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses. |
| AMG 162- 180 mg q 4 weeks | GENETIC | A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses. |
Inclusion Criteria: * Patients at least 18 years of age with histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma * Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma * Currently receiving IV bisphosphonates * Urinary N-Telopeptide (uNTx) greater...
AMG 162 q 12 weeks was studied for bone metastases in men with hormone-refractory prostate cancer. The Phase 2 trial also enrolled subjects with bone metastases from advanced breast cancer, advanced cancer, or multiple myeloma who were being treated with intravenous bisphosphonates.
Amgen Inc. (ticker AMGN) is the developer of AMG 162 q 12 weeks. The company sponsored the Phase 2 study of this dosing regimen in patients with bone metastases receiving intravenous bisphosphonates.
AMG 162 q 12 weeks is in Phase 2 development. It is an investigational regimen and is not described as approved. The single Phase 2 trial of this regimen has been completed, and no trials of it are currently active.
AMG 162 q 12 weeks was evaluated in the completed Phase 2 trial NCT00104650, titled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates. The trial enrolled 111 participants, was randomized, and used an active control.