Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients (MetAb-Pro)
Verified September 2014 by Kantonsspital Graubünden
Information provided by (Responsible Party):
Michael Mark, Kantonsspital Graubünden
First received: August 28, 2012
Last updated: September 9, 2014
Last verified: September 2014
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
Metastatic Prostate Cancer
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Metformin 2x1000mg orally per day
Adding Metformin to Abiraterone in case of PSA-Progression
Other Name: Abiraterone
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
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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
|Chur, Graubünden, Switzerland, 7000 |
|Principal Investigator: michael mark, md |
||michael mark, md
No publications provided
||Michael Mark, assistant medical director, Kantonsspital Graubünden
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 28, 2012
||September 9, 2014
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Physiological Effects of Drugs