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Trial · Interventional

TerminatedPhase 1Registry data

A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity

NCTNCT01262664 (opens ClinicalTrials.gov in a new tab)Other id2010-0369Other idNCI-2011-00300

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
20122014201620182020
  1. Ph 1

    A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity

    NCT01262664

    24 May 2012 to 2 Jan 2019

    Terminated

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.

  1. 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.

  2. 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
Inclusion Criteria: 1. Have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a BMI defined as obese (i.e. \>30 kg/m2). Any histologic variant is acceptable other than small cell carcinoma. 2. Have been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trial. 3. Patients with castrate resistant prostate cancer (CRPC) must have no standard options for therapy. Prior to registration on the study, patients with CRPC must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial). 4. Have an ECOG performance status 0, 1 or 2 5. Have adequate bone marrow function defined as an absolute peripheral granulocyte count of \>/= 1,000/mm\^3 and platelet count of \>/= 100,000/mm\^3; hemoglobin \>/= 8.0 g/dL (without transfusion or growth factor support) 6. Have adequate hepatic function defined as a total bilirubin of \</= 1.5 mg/dl and AST \</= 2x the upper limits of normal 7. Have adequate renal function defined as serum creatinine \</= 1.5x the upper limit of normal or creatinine clearance \>/= 60 mL/min (measured or calculated). In addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. EXCEPTION: Patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting. 8. Have adequate cardiovascular function as defined by: i) a normal B-type Natruetic Peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ECG. If these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (MUGA) showing an EF of 45% or greater with no more than "mild" diastolic dysfunction and a BNP of \< 200 pg/mL to be eligible. 9. Sign the current IRB approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution Exclusion Criteria: 1. Small cell prostate cancer 2. Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy 3. Any of the following in previous 6 months: NYHA Class III/IV congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ECG or serologic criteria) 4. Significant co-morbidity that could affect the safety or evaluability of participants, specifically including: i) Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. Note that this may be better established with home BP readings than with clinic visit results. Note further that this is NOT a criterion related to particular BP results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. The intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, NOT to exclude patients who may be hypertensive acutely. There are no absolute criteria for BP readings with respect to eligibility (as determined by treating physician). 5. ( # 9 cont'd) (ii) Uncontrolled diabetes mellitus, defined as: Hgb A1c \>8.5%; or symptomatic hypoglycemic episodes \> 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to \>300 mg/dL in prior two months--unless clearly iatrogenic and the cause has been eliminated iii) Lung disease requiring supplemental oxygen iv) Known chronic liver disease causing either fibrosis or synthetic dysfunction v) Known HIV infection vi) Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care. 6. Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. EXCEPTION: Non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility. 7. Patients require ongoing therapy with non-steroidal anti-inflammatory drugs (NSAIDs), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less). 8. Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug. 9. Unwillingness to maintain adequate contraception measures for the entire course of the study 10. Age \< 18 years.

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