Metastatic Colorectal CancerPhase 3NCT02605044
Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer
A Phase 3 study testing Masitinib (AB1010) and FOLFIRI in people with Metastatic Colorectal Cancer, run by AB Science at 3 sites in 3 countries.
Trial summary
The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Masitinib (AB1010) and FOLFIRI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2014to Dec 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with non-resectable metastatic colorectal cancer
- Metastatic disease not amenable to surgical resection
- Patient in second line treatment after progression according to RECIST criteria
- Patient with measurable lesions according to RECIST criteria (version 1.1)
- Patient eligible for a standard second line treatment with FOLFIRI
- Patient with ECOG ≤ 2
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- Patient with adequate organ function
- Patient with life expectancy > 3 months
- Female or male patient ≥ 18
- Patient weight > 40 kg and BMI > 18
Who cannot join
- Patient who cannot receive FOLFIRI
- More than 1 prior chemotherapy regimens for metastatic colorectal cancer
- Pregnant, intent to be pregnant, or nursing female patient
- Patient with any chronic inflammatory bowel disease
- Patient treated for a cancer other than colorectal cancer within five years before enrollment
- Patient with an hepatic involvement > 50%
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- Patient with active central nervous system (CNS) metastasis or history of CNS metastases
- Patient with an active infection
- Patient presenting with cardiac disorders
- Any previous treatment with an investigational agent or chemotherapy or biological agent within four weeks prior to baseline.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
France1 site
Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc
Paris, 75
United Kingdom1 site
Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road
London, W12 0HS
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 FOLFIRI (Irinotecan, 5-fluorouracil and Folinic Acid) to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer
The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Masitinib (AB1010), FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masitinib (AB1010)Drug
FOLFIRIDrug
| Study group | Role | What they receive |
|---|---|---|
| Masitinib + FOLFIRI | Experimental | masitinib + FOLFIRI Receives: Drug: Masitinib (AB1010); Drug: FOLFIRI |
| Placebo + FOLFIRI | Placebo comparator | Placebo + FOLFIRI Receives: Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival 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
Secondary outcomes (2)
Survival rate
Survival rate is defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Measured: Every 24 weeks, assessed up to 60 months
Progression Free Survival (PFS)
Progression Free Survival 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 by the investigator on CT scan according to RECIST 1.1 criteria
Measured: From day of randomization to disease progression or 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 posted16 Nov 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Sponsor decision based on portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien Taieb, PhD, MD, Principal investigator, Hôpital Européen Georges Pompidou, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605044
- Sponsor's protocol ID
- AB12006
- Status last verified
- Feb 2019
- First submitted
- 5 Nov 2015
- Last updated
- 11 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. 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 FOLFIRI (Irinotecan, 5-fluorouracil and Folinic Acid) to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02605044
- Acronym / sponsor ID
- AB12006
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on portfolio prioritization
- Enrolment
- 123 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Nov 2015 (estimated)
- 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.
The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masitinib + FOLFIRI | Experimental | Drug: Masitinib (AB1010), Drug: FOLFIRImasitinib + FOLFIRI |
| Placebo + FOLFIRI | Placebo comparator | Drug: FOLFIRIPlacebo + FOLFIRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient with non-resectable metastatic colorectal cancer
- Metastatic disease not amenable to surgical resection
- Patient in second line treatment after progression according to RECIST criteria
- Patient with measurable lesions according to RECIST criteria (version 1.1)
- Patient eligible for a standard second line treatment with FOLFIRI
Key exclusion criteria (10 listed)
- Patient who cannot receive FOLFIRI
- More than 1 prior chemotherapy regimens for metastatic colorectal cancer
- Pregnant, intent to be pregnant, or nursing female patient
- Patient with any chronic inflammatory bowel disease
- Patient treated for a cancer other than colorectal cancer within five years before enrollment
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 |
|---|---|---|
| Masitinib (AB1010) | Drug | Masitinib + FOLFIRI |
| FOLFIRI | Drug | Masitinib + FOLFIRI, Placebo + FOLFIRI |
Primary outcome
Overall survival
Time frame: From day of randomization to death, assessed for a maximum of 60 months
Overall survival 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.
2 secondary outcomes
Survival rate
Time frame: Every 24 weeks, assessed up to 60 months
Progression Free Survival (PFS)
Time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
Results and safety
The study was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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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.
Julien Taieb, PhD, MD principal investigator
Hôpital Européen Georges Pompidou, Paris, France
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Masitinib (AB1010) and FOLFIRI in people with Metastatic Colorectal Cancer, run by AB Science at 3 sites in 3 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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Singapore, United Kingdom. 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 was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
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?
Overall survival (time frame: From day of randomization to 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 11 Feb 2019.