A Phase 2 interventional study of TPI 287 and TPI 287 in Prostate Cancer, sponsored by Cortice Biosciences, Inc.. Terminated at 6 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-22.
Sponsored by Cortice Biosciences, Inc. · Phase 2, Interventional, and Treatment
The primary objective of the study is to determine the response rate to TPI 287 in patients with metastatic, hormone-refractory prostate cancer who have had one prior taxane regimen.
This is an open-label, multi-center, 2-stage Simon design, Phase 2 study of TPI 287 in patients with metastatic, hormone-refractory prostate cancer. All patients must have received prior taxane therapy. Up to 80 patients will be enrolled and stratified based on duration of cumulative exposure to a single prior taxane regimen. A single taxane regimen is considered to he a taxane or taxane containing therapy administered on a defined schedule with no more than 2 months' interruption between treatments, and total exposure will be assessed by the number of months on that schedule.
One stratum (up to 40 patients) will consist of patients who have had over 3 months (up to a maximum of 10 months) exposure to a taxane regimen, who then have documented progression of disease (initially taxane sensitive). The second stratum (up to 40 patients) will consist of patients considered primarily resistant to taxanes who have had documented progressive disease as best response after exposure to a single taxane regimen for less than or equal to 3 months. Patients may have received prior hormonal therapy and/or bisphosphonates and may continue on these therapies.
In the first stage of the trial, 22 patients in each stratum will be treated with TPI 287 intravenously every 21 days. If 1 or fewer patients in either stratum demonstrate a response in this first stage, the trial will be discontinued for that stratum. Otherwise, an additional 18 patients in the stratum showing 2 or more responses will be enrolled in the second stage of the study. If 4 or fewer patients demonstrate a response in the total study population in either stratum from stages 1 and 2, then the drug will not be considered of interest in prostate cancer for patients as defined in that stratum.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 26 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Cortice Biosciences, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients must have received only one prior regimen for their advanced disease. This regimen must have included a taxane.
Exclusion Criteria:
Drug: TPI 287
160 mg/m2 every three weeks for six cycles
160 mg/m2 intravenously over 60 minutes every three weeks until toxicity or progression of disease.
Response
Time frame: 15 months
Time to progression
Time frame: 15 months
Duration of response
Time frame: 6 months
Safety
Time frame: Continuous
This study is terminated, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Cortice Biosciences, Inc.