Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GM CSF · 1 trial · 1 indication
The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported
| Arm | Type | Description |
|---|---|---|
| GM-CSF | EXPERIMENTAL | Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol |
| Name | Type | Description |
|---|---|---|
| GM CSF | DRUG | 250 ug/m2 daily for 2 weeks followed by 2 weeks of rest |
Inclusion Criteria: 1. Men \>18 years of age. No upper age limit 2. Written informed consent approved by institutional review board should be explained to and signed by patient 3. Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason score of any sum is allowed on this s...
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GM CSF is being studied for use in prostate cancer as a maintenance therapy for patients who have responded to Taxotere. It is an investigational small molecule in Phase 2 clinical development. The drug is being evaluated in a completed clinical trial in the United States.
GM CSF is being developed by Sanofi, which trades under the ticker SNY. The company is conducting clinical research on this drug for prostate cancer. The development program includes a Phase 2 trial that has been completed.
GM CSF is in Phase 2 clinical development for prostate cancer. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial has been completed, and the drug remains under investigation for this indication.
GM CSF has one clinical trial, NCT00274287, titled "GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere." This Phase 2 study was completed in the United States and enrolled 15 male patients aged 18 years and older.
GM CSF is the same as GM-CSF, which stands for granulocyte-macrophage colony-stimulating factor. The drug is being studied for prostate cancer maintenance therapy. It is developed by Sanofi and is currently in Phase 2 clinical development.