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NCT01090765 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01090765: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01090765 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01090765, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Background: * Currently, there is no curative therapy for metastatic castrate-resistant prostate cancer (CRPC), a leading cause of death in men. However, researchers are exploring new treatments that involve drugs that prevent angiogenesis (the process by which new blood vessels are formed) and can slow or prevent tumor growth. * TRC105 is an experimental drug that blocks angiogenesis, and has been studied for possible use in treating different kinds of cancer. However, it has not been validated to treat prostate cancer in general or CRPC in particular. Objectives: * To determine the effects of TRC105 as a treatment for CRPC * To determine the safety and effectiveness of TRC105 in treating CRPC Eligibility: \- Men at least 18 years of age who have been diagnosed with castrate-resistant prostate cancer for which existing treatments have not been effective. Design: * Eligible individuals will have a series of blood and other tests to determine their suitability for participating in the study. * Participants will receive intravenous infusions of TRC105 in a 28-day treatment cycle. Participants will receive i.v. (intravenous) infusions of TRC105 every two weeks on days 1 and 15 of each 28-day cycle (cohorts 1, 2, 3, 5, and 6) and every week on days 1, 8, 15, and 22 of each 28 day cycle (cohort 4). * Participants will receive different doses of TRC105 depending on when they enter the study, up to a maximum tolerated dose or optimum treatment dose. * Frequent blood and urine tests will be performed during treatment, as well as other tests of cancer progression as directed by the study doctors. Participants will receive medicines to help prevent possible adverse side effects of TRC105, such as allergic reaction to the drug. * Participants will continue treatment with TRC105 until they or the study team decides that the medication is not beneficial. No additional testing will be required unless participants discontinue the treatment because of side effects (which the
Primary Outcome
The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.
Interventions
- DRUG TRC105
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-02-23 |
| Est. Completion | 2015-04-17 |
| Phase | Phase 1 |
What the finished NCT01090765 record still lists
NCT01090765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which TRC105 is the first listed.
NCT01090765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01090765 about?
NCT01090765 is a clinical study titled "A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)". Background: * Currently, there is no curative therapy for metastatic castrate-resistant prostate cancer (CRPC), a leading cause of death in men. However, researchers are exploring new treatments that involve drugs that prevent angiogenesis (the process by which new blood vessels are formed) and can...
What is the current status of trial NCT01090765?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-02-23. Estimated completion is 2015-04-17.
What interventions are being tested in trial NCT01090765?
The interventions under investigation include: TRC105 (DRUG).
Who is sponsoring clinical trial NCT01090765?
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 NCT01090765's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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