Trials / Terminated
TerminatedNCT01732549
A 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
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tasquinimod | A patient's dose will escalate from one level to the next, once tolerability of the current dose is established. If tolerability issues arise at 0.5 or 1 mg/day, patients will have their dose reduced to 0.25 or 0.5 mg/day, respectively. |
| DRUG | Placebo | Placebo capsules are identical to tasquinimod capsules in appearance and excipients but exclude the active compound (tasquinimod), to be taken orally once a day with water and food |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2015-02-01
- Completion
- 2015-05-01
- First posted
- 2012-11-26
- Last updated
- 2019-11-22
- Results posted
- 2016-10-03
Locations
58 sites across 11 countries: Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Lithuania, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01732549. Inclusion in this directory is not an endorsement.