drugset / Trial / NCT03761225

Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

NCT03761225 ↗

Phase 3 Completed 714 enrolled AB Science
RandomizedParallel-groupDouble-blindTreatment

Summary

Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.

Timeline

Start
2014-09
Primary completion
2020-12-15
Completion
2020-12-15

Outcome

Met primary endpoint

release “masitinib Phase 2B/ 3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy met its predefined primary endpoint.” ab-science.com ↗

release “its masitinib Phase 2B/3 study (AB12003) in metastatic castrate- resistant prostate cancer (mCRPC) eligible to chemotherapy met its predefined primary endpoint.” ab-science.com ↗

release “Masitinib Phase 2B/3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy met its predefined primary endpoint.” ab-science.com ↗

release “study AB12003 being a rare example of a phase 3 clinical trial that showed improvement in progression-free survival (PFS) for masitinib in combination with docetaxel.” ab-science.com ↗

release “key results from study AB12003 include: ▪ Masitinib (6.0 mg/kg/day) plus docetaxel conferred a significant progressio n-free survival (PFS) benefit in mCRPC patients” ab-science.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Masitinib Small molecule 6 mg/kg Oral
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Prednisone Other / unclassified — —