Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients (MetAb-Pro)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Kantonsspital Graubünden
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Michael Mark, Kantonsspital Graubünden
ClinicalTrials.gov Identifier:
NCT01677897
First received: August 28, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to assess the impact of the addition of metformin to abiraterone on survival in patients with metastatic prostate cancer


Condition Intervention Phase
Metastatic Prostate Cancer
Drug: Metformin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of the Addition of Metformin to Abiraterone in Pre-docetaxel Metastatic Castration-resistant Prostate Cancer Patients Progressing on Abiraterone Treatment (MetAb-Pro): a Phase II Pilot Study

Resource links provided by NLM:


Further study details as provided by Kantonsspital Graubünden:

Primary Outcome Measures:
  • progression free survival [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • progression free survival at 24 weeks [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • psa response [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
  • number of adverse events according to the NCI CTCAE v4.0 [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: August 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Metformin 2x1000mg orally per day
Drug: Metformin
Adding Metformin to Abiraterone in case of PSA-Progression
Other Name: Abiraterone

Detailed Description:

The purpose of this study is to assess the impact of the addition of metformin to abiraterone on survival in patients with metastatic chemotherapy-naive prostate cancer

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic adenocarcinoma of the prostate.
  • Patient must give written informed consent before registration.
  • Age ≥18 years.
  • WHO performance status 0-2.
  • Tumor progression (as defined below) after at least 1 hormonal treatment (orchiectomy, LHRH agonist) with documented total testosterone levels ≤ 1.7 nmol/L (≤ 50 ng/dL). Ongoing concurrent use of LHRH agonist is required if the patient has not been surgically castrated.
  • PSA progression during treatment with abiraterone (at least 12 weeks of treatment) defined as follows:

    • In case PSA levels had not decreased under treatment: ≥ 25% increase over baseline (at registration) AND an increase in the absolute PSA value of ≥ 5 ng/mL.
    • In case of PSA response < 50% under treatment: ≥ 25% increase over the nadir AND an increase in the absolute PSA value of ≥ 5 ng/mL.
    • In case of PSA response ≥ 50% under treatment: ≥ 50% increase over the nadir AND an increase in the absolute PSA value of ≥ 5 ng/mL Note: PSA progression has to be confirmed at least 1 week later. In case of confirmation the first date of PSA rise is relevant for the calculation.
  • Serum potassium ≥ 3.5mmol/L.
  • Adequate hematological values: neutrophils ≥1.5x109/L, platelets ≥100x109/L.
  • Adequate hepatic function: bilirubin ≤1.5 x ULN, ALT ≤2.5 x ULN.
  • Adequate renal function (calculated creatinine clearance ≥50 mL/min, according to the formula of Cockcroft-Gault).
  • Able to swallow study drug as whole tablet.
  • Patient compliance and geographic proximity allow proper staging and follow-up.

Exclusion Criteria:

  • Previous malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta and Tis bladder cancer.
  • Known CNS or spinal cord metastases.
  • Active autoimmune disease requiring higher doses of corticosteroid than the equivalent of prednisone 10mg/d.
  • Radiotherapy within the last 2 weeks before start of the trial treatment.
  • Patients treated with anti-androgens such as flutamide or bicalutamide, if not discontinued at least 4 weeks prior to registration in case of response or in case of no response 2 weeks prior to inclusion for wash-out reasons.
  • Prior treatment with metformin Prior treatment with metformin
  • Diabetic ketoacidosis, diabetic coma and precoma
  • Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry, except treatment with bisphosphonates and LHRH agonists.
  • Known hypersensitivity to trial drugs or hypersensitivity to any of their components.
  • Concomitant drugs contraindicated for use with the trial drugs according to the Swissmedic-approved product information.
  • Uncontrolled hypertension, history of cardiac failure NYHA class III or IV.
  • Serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled or acute severe infection, uncontrolled diabetes).
  • Active or symptomatic viral hepatitis or chronic liver disease.
  • History of pituitary or adrenal dysfunction.
  • Gastrointestinal disorder affecting absorption.
  • Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677897

Contacts
Contact: michael mark, md +410812566646 michael.mark@ksgr.ch
Contact: richard cathomas, md +410812566646 richard.cathomas@ksgr.ch

Locations
Switzerland
Kantonsspital Graubünden Recruiting
Chur, Graubünden, Switzerland, 7000
Principal Investigator: michael mark, md         
Sponsors and Collaborators
Kantonsspital Graubünden
Janssen-Cilag Ltd.
Investigators
Principal Investigator: michael mark, md Kantonsspital Graubünden
  More Information

No publications provided

Responsible Party: Michael Mark, assistant medical director, Kantonsspital Graubünden
ClinicalTrials.gov Identifier: NCT01677897     History of Changes
Other Study ID Numbers: MetAb-Pro
Study First Received: August 28, 2012
Last Updated: September 9, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014