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NCT01683994 · ClinicalTrials.gov registry record · Phase 1
Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT01683994: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01683994 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01683994, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
Background: \- Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate tumors respond to it. Docetaxel and prednisone are standard treatments for advanced prostate cancer. Researchers want to see if adding cabozantinib to these two drugs can be a safe and effective treatment for this type of cancer. Objectives: \- To test the safety and effectiveness of cabozantinib with standard treatments for advanced prostate cancer. Eligibility: \- Individuals at least 18 years of age who have advanced prostate cancer that has not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will also be performed. * Participants will receive the cancer drugs over 21-day cycles of treatment. They will take docetaxel and cabozantinib on day 1 of each cycle. Each docetaxel infusion will take about 1 hour. They will also take prednisone by mouth twice each day. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the study drugs for as long as their cancer does not worsen and side effects are not too severe.
Primary Outcome
PFS is the time interval from start of treatment to documented evidence of disease progression or death. Disease progression was assessed by the Response Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions as referenced by the smallest sum on study. Appearance of one or more new lesions on bone scan and/or two consecutive rising prostatic-specific antigen values above the baseline at a minimum of one week intervals. A normal P
Interventions
- DRUG Docetaxel
- DRUG Prednisone
- DRUG Cabozantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-09-07 |
| Est. Completion | 2019-01-16 |
| Phase | Phase 1 |
What the finished NCT01683994 record still lists
NCT01683994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT01683994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01683994 about?
NCT01683994 is a clinical study titled "Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer". Background: \- Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate tumors respond to it. Docetaxel and prednisone are standard treatments for advanced prostate cancer. Researchers want...
What is the current status of trial NCT01683994?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-09-07. Estimated completion is 2019-01-16.
What interventions are being tested in trial NCT01683994?
The interventions under investigation include: Docetaxel (DRUG), Prednisone (DRUG), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT01683994?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01683994's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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