NCT03761225

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
714

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_3

Geographic Reach
6 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

6.3 years

First QC Date

November 30, 2018

Last Update Submit

September 27, 2023

Conditions

Metastatic Castrate Resistant Prostate Cancer

Keywords

metastatic castration-resistant prostate cancermetastatic hormone-resistant prostate cancertyrosine kinase inhibitormCRPCmHRPC

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Progression Free Survival (PFS) is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.

    From day of randomization to disease progression or death, assessed for a maximum of 60 months

Secondary Outcomes (1)

  • Overall Survival

    From day of randomization to death, assessed for a maximum of 60 months

Study Arms (2)

Masitinib & docetaxel

EXPERIMENTAL

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.

Drug: MasitinibDrug: DocetaxelDrug: Prednisone

Placebo & docetaxel

PLACEBO COMPARATOR

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.

Drug: DocetaxelDrug: PrednisoneDrug: Placebo

Interventions

MasitinibDRUG
Also known as: AB1010
Masitinib & docetaxel
DocetaxelDRUG
Masitinib & docetaxelPlacebo & docetaxel
PrednisoneDRUG
Masitinib & docetaxelPlacebo & docetaxel
PlaceboDRUG
Placebo & docetaxel

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Patient with evidence of progressive metastatic disease as assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.
  • Patient with adequate organ function as per protocol

You may not qualify if:

  • \. Patient who has been previously treated with chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, 13001, Canada

Location

Polyclinique d'oncologie de Gentilly

Nancy, 54100, France

Location

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, 226014, India

Location

Centro di Riferimento Oncologico

Aviano, 33081, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56100, Italy

Location

Universiti Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

Clinic Andros LLC

Saint Petersburg, 197136, Russia

Location

MeSH Terms

Interventions

masitinibDocetaxelPrednisone

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Dominique Spaeth, MD

    Polyclinique d'oncologie de Gentilly, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 3, 2018

Study Start

September 1, 2014

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)IT(3)IN(1)CA(1)MY(1)RU(2)