AzTrials
AzTrials

Prostate CancerPhase 1NCT01262664

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

A Phase 1 study testing Prohibitin-TP01 in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Prohibitin-TP01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
24 May 2012to 2 Jan 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

The Study Drug:

PROHIBITIN-TP01 is designed to destroy "white fat" (the type of fat that collects around the stomach and is associated with obesity in men). Fat is known to produce substances that can promote prostate cancer growth. Investigators want to learn if decreasing fat can slow the growth of prostate cancer.

This is the first study using PROHIBITIN-TP01 in humans.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of PROHIBITIN-TP01 based on when you join this study. Up to 5 dose levels of PROHIBITIN-TP01 will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of PROHIBITIN-TP01 is found.

Study Drug Administration:

You will receive PROHIBITIN-TP01 as an injection under the skin 1 time each day for 28 days.

Study Visits:

On Days 1, 8, 15 and 22:

  • You will have a physical exam, including measurement of your weight.
  • Your performance status will be recorded.
  • Blood (about 3 teaspoons) will be drawn for routine tests. You will be required to fast for about 8 hours before this blood test.
  • You will be asked about any symptoms or side effects you may have had since your last visit and about any other drugs you may be taking.
  • Blood (about 2 teaspoons) will be drawn for PK testing 10 minutes, 30 minutes, 1 hour, and 4 hours after you receive the Day 1 and Day 22 dose of PROHIBITIN-TP01.
  • You will have an ECG either right before or within 4 hours after you receive the study drug (Days 1, 15, and 22 only).

Length of Study Drug Administration:

You will receive the study drug for up to 28 days. You will no longer be able to receive the study drug if the disease gets worse or intolerable side effects occur.

Follow-up Visit:

Within 7 days after you stop receiving the study drug, the following procedures will be performed:

  • You will have a physical exam, including measurement of your weight, as well as measurements of your waist and hips.
  • Your performance status will be recorded.
  • Blood (about 3 teaspoons) will be drawn for routine tests. This testing will also include a measurement of your PSA, testosterone, cholesterol, and other research tests that may show how the study drug affected you.
  • You will be asked about symptoms or any side effects you have had since your last visit.
  • You will have CT or MRI scans and a chest x-ray to check the status of the disease.
  • You will have an ECG

Thirty (30) days after you stop receiving the study drug, the following procedures will be performed:

  • You will have a physical exam, including measurement of your weight.
  • Your performance status will be recorded.
  • Blood (about 3 teaspoons) will be drawn for routine tests.
  • Blood (about 3 teaspoons - in addition to that listed above) will be collected to learn if your immune system reacts to PROHIBITIN-TP01 by forming antibodies.
  • You will be asked about symptoms or any side effects you have had since your last visit.
  • You will have an ECG

Long-Term Follow-Up:

You will be contacted by phone or e-mail every 3 months for 1 year and asked about your kidney function, current weight, prostate cancer status, and any side effects you may have had. Each phone call will last up to 5 minutes.

This is an investigational study. PROHIBITIN-TP01 is not FDA approved or commercially available. It is currently being used for research purposes only.

Up to 39 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions
Prostate Cancer
Being tested
Prohibitin-TP01
Keywords
Advanced prostate cancer, Castrate-Resistant Prostate Cancer, Prohibitin-TP01
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prohibitin-TP01Drug

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

Study groups in NCT01262664
Study groupRoleWhat they receive
Prohibitin-TP01ExperimentalProhibitin-TP01 starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.
Receives: Drug: Prohibitin-TP01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 58 days

  2. 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.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2010 (estimated)
  2. Study start24 May 2012
  3. Primary completion2 Jan 2019
  4. Study completion2 Jan 2019

Why it stopped: Terminated per PI's request

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01262664
Sponsor's protocol ID
2010-0369
Other IDs
NCI-2011-00300
Status last verified
Jan 2019
First submitted
16 Dec 2010
Last updated
4 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Prohibitin-TP01 in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Terminated per PI's request). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptable Dose of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity (time frame: 58 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01262664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in