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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
The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.
Details
| Lead sponsor | Ipsen |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 144 |
| Start date | 2013-01 |
| Completion | 2015-05 |
Conditions
- Metastatic Castrate Resistant Prostate Cancer
Interventions
- Tasquinimod
- Placebo
Primary outcomes
- Time to Radiological Progression Free Survival [PFS] — Every 8 weeks until disease progression documentation (approximately up to 2.5 years)
The time from the date of randomisation to the date of radiological progression or death due to any cause. Radiological progression was defined \- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions \- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions.
Countries
Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Lithuania, Poland, Spain, United Kingdom