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 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 2010-0369NCI-2011-00300
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Advanced prostate cancer; Castrate-Resistant Prostate Cancer; Prohibitin-TP01

Outcome Measures

Primary Outcomes (2)

• Acceptable Dose of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity

  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.

  58 days

• Biologic Activity of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity

  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.

  28 days

Study Arms (1)

Prohibitin-TP01

EXPERIMENTAL

Prohibitin-TP01 starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.

Drug: Prohibitin-TP01

Interventions

Prohibitin-TP01 DRUG

Starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.

Prohibitin-TP01

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).
• Have an ECOG performance status 0, 1 or 2
• 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)
• Have adequate hepatic function defined as a total bilirubin of \</= 1.5 mg/dl and AST \</= 2x the upper limits of normal
• 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.
• 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.
• 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

You may not qualify if:

• Small cell prostate cancer
• Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
• 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)
• 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).
• ( # 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.
• 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.
• 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).
• Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug.
• Unwillingness to maintain adequate contraception measures for the entire course of the study
• Age \< 18 years.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Amado Zurita, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: May 24, 2012
• Primary Completion: January 2, 2019
• Study Completion: January 2, 2019
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

US (1)