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

NCT02605044 | Terminated Phase 3

• 1 other identifier: AB12006
• Study Type: interventional
• Target: 123
• Locations: 3 countries
• Sites: 3

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Survival rate

  Every 24 weeks, assessed up to 60 months

• Progression Free Survival (PFS)

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

Study Arms (2)

Masitinib + FOLFIRI

EXPERIMENTAL

masitinib + FOLFIRI

Drug: Masitinib (AB1010); Drug: FOLFIRI

Placebo + FOLFIRI

PLACEBO COMPARATOR

Placebo + FOLFIRI

Drug: FOLFIRI

Interventions

Masitinib (AB1010) DRUG

Masitinib + FOLFIRI

FOLFIRI DRUG

Masitinib + FOLFIRI; Placebo + FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AB Science: lead

Study Sites (3)

Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc

Paris, 75, France

Location

National Cancer Center, 11 Hospital Drive

Singapore, 169610, Singapore

Location

Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

masitinib; IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Julien Taieb, PhD, MD

  Hôpital Européen Georges Pompidou, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 16, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

FR (1); GB (1); SG (1)