Metastatic Castrate Resistant Prostate CancerPhase 3NCT03761225
Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer
A Phase 3 study testing Masitinib, Docetaxel and Prednisone in people with Metastatic Castrate Resistant Prostate Cancer, run by AB Science at 9 sites in 6 countries.
Trial summary
Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castrate Resistant Prostate Cancer
- What is being tested?
- Masitinib, Docetaxel and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 714 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Sep 2014to 15 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Patient who has been previously treated with chemotherapy.
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Italy3 sites
Centro di Riferimento Oncologico
Aviano, 33081
Istituto Europeo di Oncologia
Milan, 20141
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100
Russia2 sites
Clinical Oncology Dispensary
Omsk, 644013
Clinic Andros LLC
Saint Petersburg, 197136
India1 site
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, 226014
About this study
Official title: 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)
Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.
Read the detailed description
The objective of this study is to evaluate the efficacy and safety of masitinib in combination with docetaxel and prednisone with respect to placebo in combination with docetaxel and prednisone in the treatment of first line metastatic Castrate Resistant Prostate Cancer (mCRPC). Approximately 580 patients will be randomized in 2 groups with a ratio 1:1. The primary outcome measure is progression free survival. Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.
- Being tested
- Masitinib, Docetaxel, Prednisone, Placebo
- Keywords
- metastatic castration-resistant prostate cancer, metastatic hormone-resistant prostate cancer, tyrosine kinase inhibitor, mCRPC, mHRPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MasitinibDrug
Also called AB1010
DocetaxelDrug
PrednisoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Masitinib; Drug: Docetaxel; Drug: 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. Receives: Drug: Docetaxel; Drug: Prednisone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day of randomization to disease progression or death, assessed for a maximum of 60 months
Secondary outcomes (1)
Overall Survival
Overall survival (OS) is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.
Measured: From day of randomization to death, assessed for a maximum of 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study startSep 2014
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castrate Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 714 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominique Spaeth, MD, Principal investigator, Polyclinique d'oncologie de Gentilly, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761225
- Sponsor's protocol ID
- AB12003
- Status last verified
- Sep 2023
- First submitted
- 30 Nov 2018
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03761225
- Acronym / sponsor ID
- AB12003
- Keywords
- metastatic castration-resistant prostate cancer, metastatic hormone-resistant prostate cancer, tyrosine kinase inhibitor, mCRPC, mHRPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 714 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.
Detailed description
The objective of this study is to evaluate the efficacy and safety of masitinib in combination with docetaxel and prednisone with respect to placebo in combination with docetaxel and prednisone in the treatment of first line metastatic Castrate Resistant Prostate Cancer (mCRPC). Approximately 580 patients will be randomized in 2 groups with a ratio 1:1. The primary outcome measure is progression free survival. Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masitinib & docetaxel | Experimental | Drug: Masitinib, Drug: Docetaxel, Drug: PrednisoneParticipants 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. |
| Placebo & docetaxel | Placebo comparator | Drug: Docetaxel, Drug: Prednisone, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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
Key exclusion criteria (1 listed)
- 1. Patient who has been previously treated with chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MasitinibAlso: AB1010 | Drug | Masitinib & docetaxel |
| Docetaxel | Drug | Masitinib & docetaxel, Placebo & docetaxel |
| Prednisone | Drug | Masitinib & docetaxel, Placebo & docetaxel |
| Placebo | Drug | Placebo & docetaxel |
Primary outcome
Progression Free Survival
Time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
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.
1 secondary outcome
Overall Survival
Time frame: From day of randomization to death, assessed for a maximum of 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castrate Resistant Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Spaeth, MD principal investigator
Polyclinique d'oncologie de Gentilly, Nancy, France
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Masitinib, Docetaxel and Prednisone in people with Metastatic Castrate Resistant Prostate Cancer, run by AB Science at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Russia, Canada, France, India and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.