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Filgrastim-SD/01 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Filgrastim-SD/01 | EXPERIMENTAL | 6 mg SC, Day 9, 24 hours after the end of the chemotherapy infusion |
| Name | Type | Description |
|---|---|---|
| Filgrastim-SD/01 | DRUG | 6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion) |
* Histologically or cytologically documented non-small cell lung cancer * Subjects must have stage IV or IIIB NSCLC * 0-1 prior treatment regimens of chemotherapy * Subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies * Age \> 18 years ...
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Filgrastim-SD/01 was studied in non-small cell lung cancer, specifically as supportive care alongside docetaxel and gemcitabine chemotherapy in patients with advanced non-small cell lung carcinoma. It was evaluated in a Phase 2 trial of 40 patients in the United States. It is an investigational agent and is not an approved therapy.
Filgrastim-SD/01 is being developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen sponsored the Phase 2 study of the agent in advanced non-small cell lung carcinoma.
Filgrastim-SD/01 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study enrolled 40 patients with advanced non-small cell lung carcinoma and evaluated the agent with docetaxel and gemcitabine chemotherapy.
Filgrastim-SD/01 has been studied in one clinical trial, NCT00050674, titled Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma. The Phase 2 trial enrolled 40 patients in the United States, included adults 18 years and older of any sex, and has been completed.
Filgrastim-SD/01 is not approved and remains an investigational agent in clinical development. Its only recorded study, a completed Phase 2 trial in advanced non-small cell lung carcinoma, evaluated it as supportive care with docetaxel and gemcitabine. No regulatory approval has been granted for this agent.