Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients | RxWiki

Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients

Overview[ - collapse ][ - ]

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	Metastatic Prostate Cancer
Intervention	Drug: Metformin
Phase	Phase 2
Sponsor	Kantonsspital Graubünden
Responsible Party	Kantonsspital Graubünden
ClinicalTrials.gov Identifier	NCT01677897
First Received	August 28, 2012
Last Updated	August 29, 2012
Last verified	August 2012

Tracking Information[ + expand ][ + ]

First Received Date	August 28, 2012
Last Updated Date	August 29, 2012
Start Date	November 2012
Estimated Primary Completion Date	August 2014
Current Primary Outcome Measures	progression free survival [Time Frame: at 12 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	overall survival [Time Frame: up to 2 years] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients
Official Title	Impact of the Addition of Metformin to Abiraterone in Post-docetaxel Metastatic Castration-resistant Prostate Cancer Patients Progressing on Abiraterone Treatment (MetAb-Pro): a Phase II Pilot Study
Brief Summary	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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Metastatic Prostate Cancer
Intervention	Drug: Metformin Other Names: Abiraterone
Study Arm (s)	Experimental: Metformin Metformin 2x1000mg orally per day

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	25
Estimated Completion Date	August 2014
Estimated Primary Completion Date	November 2013
Eligibility 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. - Patient must have received first line chemotherapy with docetaxel. - 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 - 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.
Gender	Male
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: michael mark, md +410812566646 michael.mark@ksgr.ch
Location Countries	Switzerland

Administrative Information[ + expand ][ + ]

NCT Number	NCT01677897
Other Study ID Numbers	MetAb-Pro
Has Data Monitoring Committee	Yes
Information Provided By	Kantonsspital Graubünden
Study Sponsor	Kantonsspital Graubünden
Collaborators	Janssen-Cilag AG
Investigators	Principal Investigator: michael mark, md Kantonsspital Graubünden
Verification Date	August 2012

Locations[ + expand ][ + ]