- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465345
Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
August 1, 2018 updated by: Medical University of South Carolina
Phase 1b Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
The overall goal of this study is to identify a safe dose of metformin, in combination with oligomeric procyanidin complex (OPC) for pharmacologic reduction of AGE levels in patients with prostate cancer.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
AGEs (advanced glycation endpoints) are a type of metabolite, or substance, found in the food.
The AGE content in food is determined by the types of food you eat and also how you prepare your food.
The researchers helping conduct this study have found a potential link between AGE levels and cancer.
The purpose of this study is to identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer.
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer.
- Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be <50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain <50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible.
Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows:
- Hematology parameters: ANC >1000/mcL, platelets > 100,000/mcL, Hgb >8.0gm/dL
- Renal Function: eGFR of ≥ 45mls/min using Cockkroft and Gault formula (see appendix C).
- Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN, Prior radiation therapy allowed
- Subjects may have diabetes mellitus but must not be taking metformin.
- Able to swallow and retain oral medication
- ECOG performance status of 0 - 2
- Ability to sign written informed consent
- Testosterone level <50ng/dL at time of enrollment.
- Age 18 or older.
Exclusion Criteria:
- Known allergy to grapes or grape seed
- Known hypersensitivity or intolerance to metformin.
- Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as NYHA Class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day).
- Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
- History of receiving more than 2 classes of ADT.
- Current use of metformin, or strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine
- PSA doubling time of <6 months, measured over the 3 months prior to enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin + OPC dose escalation
|
Metformin: The starting dose for Metformin is 850mg once a day, the second dose is 850mg once a day; the third dose level is 850mg twice a day; the fourth dose level is 850mg twice a day.
Each dose level lasts for 28 days.
OPC: The starting dose for OPC is 500mg once a day; the second dose is 1000mg once a day; the third dose level is 1000mg once a day; the fourth dose level is 1500mg once a day.
Each dose level lasts for 28 days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose (MTD) of metformin in combination with OPC in PCa subjects.
Time Frame: 112 days
|
112 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between changes to AGE level and changes to PSA.
Time Frame: 112 days
|
112 days
|
|
Correlation between changes to AGE level and changes to BMI.
Time Frame: 112 days
|
112 days
|
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Correlation between changes to AGE level and changes to insulin resistance.
Time Frame: 112 days
|
112 days
|
|
Correlation between changes to AGE level and changes to A1C.
Time Frame: 112 days
|
112 days
|
|
Correlations between changes to AGE level and changes to testosterone.
Time Frame: 112 days
|
112 days
|
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Correlation between changes to AGE level and changes to diet.
Time Frame: 112 days
|
112 days
|
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Correlation between changes to AGE level and changes to quality of life.
Time Frame: 112 days
|
FACT-P and AUA questionnaires
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112 days
|
Frequency of adverse events as assessed by CTCAE v. 4
Time Frame: 112 days
|
Toxicities will be tabulated by type and grade and the proportion of patients with grade 3, grade 4 or an SAE will be estimated with a 90% confidence interval.
|
112 days
|
Correlation between AGE levels and sRAGE (soluble receptor for AGE) expression and signaling.
Time Frame: 112 days
|
112 days
|
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Correlation between changes to AGE level and OPC metabolite levels.
Time Frame: 112 days
|
112 days
|
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Correlation between changes to AGE level and changes in the stool. microbiome.
Time Frame: 112 days
|
112 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Lilly, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2018
Primary Completion (Actual)
July 11, 2018
Study Completion (Actual)
July 11, 2018
Study Registration Dates
First Submitted
February 27, 2018
First Submitted That Met QC Criteria
March 7, 2018
First Posted (Actual)
March 14, 2018
Study Record Updates
Last Update Posted (Actual)
August 3, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Protective Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antioxidants
- Metformin
- Proanthocyanidin
- Procyanidin
Other Study ID Numbers
- 102797
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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