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NCT01469338 · ClinicalTrials.gov registry record · Phase 2
Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel
A Phase 2 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01469338: Clinical Trial Phase 2 study, sponsored by University of Southern California.
NCT01469338 is a Phase 2 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01469338, a Phase 2 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase II trial studies how well octreotide works in reducing diarrhea in patients receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously treated with docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several hormones in patients receiving chemotherapy for prostate cancer
Primary Outcome
Defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria as an increase in frequency of 4 or greater stools per day over baseline, incontinence, diarrhea warranting hospitalization or diarrhea limiting self-care activities of daily living (ADL). Baseline frequency will be defined in the pre-treatment assessment from cycle 1 as the maximum number of stools in one 24 hour period during the past 2 weeks. Any incidence of grade 2 or greater diarrhea during treatment or for up
Interventions
- DRUG prednisone
- OTHER questionnaire administration
- DRUG octreotide pamoate
- DRUG octreotide acetate
- DRUG cabazitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
Why NCT01469338 stopped before completion
NCT01469338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which prednisone is the first listed.
NCT01469338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01469338 about?
NCT01469338 is a clinical study titled "Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel". This phase II trial studies how well octreotide works in reducing diarrhea in patients receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously treated with docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several hormones in patients receiv...
What is the current status of trial NCT01469338?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2012-07. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01469338?
The interventions under investigation include: prednisone (DRUG), questionnaire administration (OTHER), octreotide pamoate (DRUG), octreotide acetate (DRUG), cabazitaxel (DRUG).
Who is sponsoring clinical trial NCT01469338?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01469338's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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