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Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02605044
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : November 16, 2015
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Masitinib (AB1010) Drug: FOLFIRI Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Masitinib + FOLFIRI
masitinib + FOLFIRI
Drug: Masitinib (AB1010)
Drug: FOLFIRI
Placebo Comparator: Placebo + FOLFIRI
Placebo + FOLFIRI
Drug: FOLFIRI



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Survival rate [ Time Frame: Every 24 weeks, assessed up to 60 months ]
    Survival rate is defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution

  2. Progression Free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patient with adequate organ function
  • Patient with life expectancy > 3 months
  • Female or male patient ≥ 18
  • Patient weight > 40 kg and BMI > 18

Exclusion Criteria:

  • 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%
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605044


Locations
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France
Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc
Paris, France, 75
Singapore
National Cancer Center, 11 Hospital Drive
Singapore, Singapore, 169610
United Kingdom
Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road
London, United Kingdom, W12 0HS
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Julien Taieb, PhD, MD Hôpital Européen Georges Pompidou, Paris, France

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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT02605044     History of Changes
Other Study ID Numbers: AB12006
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases