Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 102 · 2 trials · 6 indications
The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.
| Arm | Type | Description |
|---|---|---|
| AMG 102 with Avastin | EXPERIMENTAL | Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks. |
| Phase 1b - AMG 102 | OTHER | Phase 1b is an open-label study with AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed, will be administered by IV Q3W in combination with MP. |
| Phase 2 Arm A - AMG 102 + MP | EXPERIMENTAL | AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W. |
| Phase 2 Arm C- PLACEBO | PLACEBO_COMPARATOR | Placebo in combination with MP, will be administered by IV Q3W. |
| Phase 2 Arm B - AMG 102 + MP | EXPERIMENTAL | Safe dose level in phase 1b of AMG 102 + MP will be administered by Q3W |
| Name | Type | Description |
|---|---|---|
| AMG 102 | DRUG | AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes. |
| Avastin | DRUG | Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102. |
| Mitoxantrone | DRUG | Administered Q3W for a maximum of 12 cyles |
| Placebo | DRUG | Placebo |
| Prednisone | DRUG | 5 mg orally BID |
Inclusion Criteria: * Patients must have recurrent histologically confirmed diagnosis of WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. * Age ≥ 18 years. * Karnofsky ≥ 60%. * An interval of at least 4 weeks between either prior tumor b...
AMG 102 is an investigational oncology drug being studied for the treatment of cancer, including non-small-cell lung cancer, glioblastoma multiforme, and castrate-resistant prostate cancer. It is a small molecule being developed by Amgen Inc. and is currently in clinical trials.
AMG 102 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is an investigational small molecule in the oncology therapeutic area.
AMG 102 is in clinical development, with completed trials in Phase 1 and Phase 2. It is an investigational drug and has not been approved by the FDA. Its development includes studies in various cancer types.
AMG 102 has been studied in several completed clinical trials. NCT00770848 tested it with mitoxantrone and prednisone in castrate-resistant prostate cancer. NCT01113398 evaluated it with Avastin for recurrent malignant glioma. NCT01233687 studied it with erlotinib for advanced non-small-cell lung cancer.
AMG 102 is also known as rilotumumab, a monoclonal antibody targeting hepatocyte growth factor. It has been investigated in oncology clinical trials for various solid tumors, including glioblastoma and non-small-cell lung cancer.