Maintenance Therapy with Tasquinimod in patients with mCRPC

• Research type

  Research Study

• Full title

  A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PROOF OF CONCEPT STUDY OF MAINTENANCE THERAPY WITH TASQUINIMOD IN PATIENTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER WHO ARE NOT PROGRESSING AFTER A FIRST LINE DOCETAXEL BASED CHEMOTHERAPY

• IRAS ID

  109147

• Contact name

  Simon Chowdhury

• Sponsor organisation

  Ipsen Pharma

• Eudract number

  2012-001038-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Prostate cancer is the second most common cancer in males worldwide. Patients with prostate cancer may be treated with androgen deprivation therapy but, although the majority of the cancers responds to it for several years, they all eventually progress to a state of (metastatic) castrate-resistant prostate cancer ((m)CRPC), which means the cancer is no longer responsive to the castration treatment.In patients with mCRPC, the current standard first line chemotherapy is docetaxel but there is no current treatment to prolong the stabilisation phase after this first line chemotherapy. Tasquinimod is a chemical substance that displays properties such as reduction of tumour growth and has demonstrated a role in delaying the progression of mCRPC and increasing the patients?? survival time. The objective of this study is to demonstrate that Tasquinimod used as maintenance therapy is active and tolerable in patients with mCRPC whose cancer has not progressed under/after a first line docetaxel chemotherapy.Although the patients?? participating in this study may not receive any personal benefit, it is expected that their participation will benefit other patients with mCRPC in the future by providing new information about the treatment/disease.This study is sponsored by Ipsen Pharma and will be conducted in oncology units within 5 to 8 countries. Around 140 patients will take part in the study, which is expected to last approximately 3.5 years.During the study, the patients with mCRPC will be randomly assigned with a ratio 1:1 to tasquinimod and placebo. The patients will initially receive tasquinimod (or corresponding placebo) 0.25 mg/day dose and doses will be escalated from 0.25 mg/day to 0.5 mg/day and then to 1 mg/day, depending on the patients?? tolerability. There will be a 2 week screening Period, a Baseline Visit for patients?? randomisation, a Treatment Period, an End of Study Treatment/Withdrawal Visit and a Follow up Period. Study visits will be conducted at 8 weekly intervals. Throughout the study, physical examinations will be performed, patients?? quality of life evaluated and blood samples collected for routine safety assessments and analysis of other parameters. The extend of the disease, the tumour measurements and bone lesions will be assessed by scans.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  12/EM/0477

• Date of REC Opinion

  5 Feb 2013

• REC opinion

  Further Information Favourable Opinion