A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity
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|ClinicalTrials.gov Identifier: NCT01262664|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2010
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Prohibitin-TP01||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity|
|Actual Study Start Date :||May 24, 2012|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
Prohibitin-TP01 starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.
Starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.
- Acceptable Dose of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity [ Time Frame: 58 days ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262664
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amado Zurita, MD||M.D. Anderson Cancer Center|