Clinical trial · Interventional
Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer
A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Docetaxel to Placebo in Combination With Docetaxel in First Line Metastatic Castrate Resistant Prostate Cancer (mCRPC)
NCT03761225CI-TRIAL-00070066completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castrate Resistant Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Masitinib | Drug | Masitinib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Masitinib & docetaxel
- description
- Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.
- interventionNames
- Drug: Masitinib
- Drug: Docetaxel
- Drug: Prednisone
- type
- PLACEBO_COMPARATOR
- label
- Placebo & docetaxel
- description
- Participants receive placebo (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.
- interventionNames
- Drug: Docetaxel
- Drug: Prednisone
- Drug: Placebo
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone \< 0.5ng/ml) with one of the following criteria: * Pre-treated with abiraterone with documented progressive disease, OR * Indicated for initiating docetaxel treatment (e.g., widespread visceral disease or rapidly progressive disease). 2. Patient with evidence of progressive metastatic disease as assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations. 3. Patient with adequate organ function as per protocol Exclusion Criteria: 1\. Patient who has been previously treated with chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.