Trial · Interventional
TerminatedPhase 1Registry dataA First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity
This trial was stopped early.
Reason given at the registry: Terminated per PI's request
Overview
- Status
- Terminated
- Phase
- Phase 1
- Enrollment
- 4 participants (actual)
- Sponsor
- M.D. Anderson Cancer Center · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 24 May 2012
- Primary completion
- 2 Jan 2019
- Completion
- 2 Jan 2019
- First posted
- 17 Dec 2010 (estimated)
- Last update posted
- 4 Jan 2019
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1Terminated
A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity
NCT0126266424 May 2012 to 2 Jan 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of this clinical research study is to find the highest tolerable dose of PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there are no standard therapy options. The safety of this drug will also be studied.
Interventions
- Prohibitin-TP01Drug
Arms1
Experimental
Prohibitin-TP01
Prohibitin-TP01 starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.
Primary outcomes2
Outcomes the sponsor listed as primary.
Acceptable Dose of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity
Time frame · 58 days
Registry description
Dose is acceptable if is not unlikely that a dose has at least a 50% response rate, and that it is not unlikely that the dose has at most a 30% toxicity rate.
Biologic Activity of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity
Time frame · 28 days
Registry description
Biologic Activity (BA) defined as loss of 10% of baseline body weight (or equivalently, a 10% reduction in BMI) as measured at the end of the 28 day dosing period.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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