Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Sponsor

AB Science (Industry)

Overall Status

Completed

CT.gov ID

NCT01694277

Collaborator

(none)

258

Enrollment

Locations

Arms

104

Duration (Months)

51.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Masitinib Drug: Sunitinib	Phase 3

Detailed Description

Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Masitinib Participants receive masitinib (12 mg/kg/day), given orally twice daily.	Drug: Masitinib 12 mg/kg/day Other Names: AB1010
Active Comparator: Sunitinib Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally	Drug: Sunitinib 50 mg/day Other Names: Sutent

Arm

Intervention/Treatment

Experimental: Masitinib

Participants receive masitinib (12 mg/kg/day), given orally twice daily.

Drug: Masitinib

12 mg/kg/day

Other Names:

AB1010

Active Comparator: Sunitinib

Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally

Drug: Sunitinib

50 mg/day

Other Names:

Sutent

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) [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

Survival rate [Every 12 weeks until study completion, assessed for a maximum of 60 months]
Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.
Progression Free Survival (PFS) [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 and/or CHOI criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main inclusion criteria include:

Patient with histological proven metastatic GIST or non-operable locally advanced GIST
Patient with c-Kit (CD117) positive tumor detected immuno-histochemically
Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment.

Main exclusion criteria include:

Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
Pregnant, or nursing female patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
2	Institut Bergonié	Bordeaux		France	33000
3	Hôpital l'Archet 2- Service de Cancérologie Digestive	Nice		France	06202
4	Istituto per la Ricerca e la Cura del Cancro (IRCC)	Candiolo		Italy	10060
5	Erasmus University Medical Center	Rotterdam		Netherlands	3015 GD