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NCT01468532 · ClinicalTrials.gov registry record · Phase 1
Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
A Phase 1 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01468532: Completed Phase 1 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT01468532 is a Phase 1 study that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468532, a Phase 1 study, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of pasireotide and to see how well it works when given together with docetaxel and prednisone in treating patients with metastatic hormone-resistant prostate cancer. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pasireotide may inhibit the secretion of hormones. Giving pasireotide together with docetaxel and prednisone may kill more tumor cells.
Primary Outcome
To identify the maximum tolerated dose (MTD) of pasireotide, The occurrence rate of binary endpoints (eg, specific types of toxicity at a certain dose level and severity grade, response, etc) will be described by point estimates and exact 90% confidence intervals (CIs) for proportions using Wilson's method.
Interventions
- DRUG prednisone
- DRUG docetaxel
- DRUG pasireotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-10 |
| Est. Completion | 2017-07-20 |
| Phase | Phase 1 |
What the finished NCT01468532 record still lists
NCT01468532 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which prednisone is the first listed.
NCT01468532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01468532 about?
NCT01468532 is a clinical study titled "Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer". This phase I/II trial studies the side effects and best dose of pasireotide and to see how well it works when given together with docetaxel and prednisone in treating patients with metastatic hormone-resistant prostate cancer. Drugs used in chemotherapy, such as docetaxel and prednisone, work in dif...
What is the current status of trial NCT01468532?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-10. Estimated completion is 2017-07-20.
What interventions are being tested in trial NCT01468532?
The interventions under investigation include: prednisone (DRUG), docetaxel (DRUG), pasireotide (DRUG).
Who is sponsoring clinical trial NCT01468532?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01468532's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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