Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ganitumab
AMG 479 · 2 trials · 8 indications
Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
| Arm | Type | Description |
|---|---|---|
| AMG 479 | EXPERIMENTAL | Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| AMG 479 | DRUG | - |
| ganitumab | BIOLOGICAL | - |
| laboratory biomarker analysis | OTHER | - |
| pharmacological study | OTHER | - |
| biopsy | PROCEDURE | - |
Inclusion Criteria: * Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors. To be classified as having a pancreatic neuroendocrine tumor, patients must have clinical evidence of currently having or having had a primary pancreatic neuroendocrine lesion. * Measurable disea...
AMG 479 was studied for the treatment of neuroendocrine tumors, including advanced carcinoid tumors and pancreatic neuroendocrine tumors. It was evaluated in a Phase 2 clinical trial in adult patients with these tumor types. It is an investigational agent and is not an approved therapy for neuroendocrine tumors.
AMG 479 is being developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen sponsored the Phase 2 study of AMG 479 in advanced carcinoid and pancreatic neuroendocrine tumors conducted in the United States.
AMG 479 is in Phase 2 development for neuroendocrine tumors. The single Phase 2 trial, NCT01024387, has been completed. No active trials are currently listed for AMG 479 in this indication, and the drug remains investigational rather than approved.
AMG 479 was evaluated in one Phase 2 trial, NCT01024387, titled AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors. The study enrolled 60 adults aged 18 years and older in the United States and has been completed. It was an uncontrolled, non-randomized, open-label study.
AMG 479 is not approved and remains an investigational drug in clinical development. Its only listed study, a completed Phase 2 trial in advanced carcinoid and pancreatic neuroendocrine tumors, does not constitute regulatory approval. No approval has been granted for AMG 479 for any indication.