NCT01694277

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_3

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

8.7 years

First QC Date

August 22, 2012

Last Update Submit

December 7, 2020

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal TumourGISTnon-resectablemetastaticsecond line treatmentresistance to imatinibtyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    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 12 weeks until study completion, assessed for a maximum of 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

EXPERIMENTAL

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

Drug: Masitinib

Sunitinib

ACTIVE COMPARATOR

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

Drug: Sunitinib

Interventions

MasitinibDRUG

12 mg/kg/day

Also known as: AB1010
Masitinib
SunitinibDRUG

50 mg/day

Also known as: Sutent
Sunitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Institut Bergonié

Bordeaux, 33000, France

Location

Hôpital l'Archet 2- Service de Cancérologie Digestive

Nice, 06202, France

Location

Istituto per la Ricerca e la Cura del Cancro (IRCC)

Candiolo, 10060, Italy

Location

Erasmus University Medical Center

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Gastrointestinal Stromal TumorsNeoplasm Metastasis

Interventions

masitinibSunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Axel Le Cesne, M.D., Ph.D

    Institute Gustave Roussy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2012

First Posted

September 27, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations

NL(1)IT(1)FR(2)US(1)