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 is an investigational gene therapy being studied for the treatment of bone metastases in men with hormone-refractory prostate cancer. It is administered every 12 weeks and is currently in Phase 2 clinical development.
AMG 162 q 12 weeks is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is in Phase 2 clinical development for bone metastases in men with hormone-refractory prostate cancer.
AMG 162 q 12 weeks is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial for the drug has been completed.
AMG 162 q 12 weeks has one completed clinical trial, identified as NCT00104650. This Phase 2 study enrolled 111 participants and evaluated the drug in subjects with advanced cancer currently being treated with intravenous bisphosphonates, including men with hormone-refractory prostate cancer and bone metastases.
Yes, the clinical trial for AMG 162 q 12 weeks, NCT00104650, was a randomized, active-controlled study. It was not double-blinded and did not use biomarker selection. The trial enrolled 111 participants and has been completed.