A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Castrate-Resistant Prostate Cancer and No Standard Treatment Options
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 Pharmacokinetic (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 prostate-specific antigen (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 computer tomography (CT) or magnetic resonance imaging (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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
Maximum Tolerated Dose (MTD) defined as that without dose-limiting toxicity 30 days after the last dose of study drug.
28 day cycle
Yes
Lance Pagliaro, MD, BA
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2010-0369
NCT01262664
May 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |