Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

• ClinicalTrials.gov Identifier: NCT01694277
• Recruitment Status: Completed
• First Posted: September 27, 2012
• Last Update Posted: December 8, 2020
• Sponsor: AB Science
• Information provided by (Responsible Party): AB Science

Tracking Information

• First Submitted Date: August 22, 2012
• First Posted Date: September 27, 2012
• Last Update Posted Date: December 8, 2020
• Study Start Date: April 2012
• Actual Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2018)

Overall Survival (OS) [ 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.

Original Primary Outcome Measures (submitted: September 25, 2012)

Overall Survival (OS) [ Time Frame: up to 24 weeks ]

Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death

Current Secondary Outcome Measures (submitted: December 7, 2018)

• Survival rate [ Time Frame: 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) [ 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 and/or CHOI criteria.

Original Secondary Outcome Measures (submitted: September 25, 2012)

• Time to Progression [ Time Frame: up to 24 weeks ]
  Time to Progression from the date of randomization until disease progression
• Overall Progression Free Survival (PFS) [ Time Frame: up to 24 weeks ]
  From the date of randomization to disease progression or death
• Survival rate [ Time Frame: up to 24 weeks ]
  from the date of randomization until death
• Objective Response Rate [ Time Frame: up to 24 weeks ]
  Partial response or total Response
• Control Disease Rate [ Time Frame: up to 24 weeks ]
  Disease Control documented partial response (PR), complete response (CR) or stable disease (SD

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastrointestinal Stromal Tumors

Intervention

• Drug: Masitinib
  12 mg/kg/day
  Other Name: AB1010
• Drug: Sunitinib
  50 mg/day
  Other Name: Sutent

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 5, 2019): 258
• Original Estimated Enrollment (submitted: September 25, 2012): 208
• Actual Study Completion Date: December 2020
• Actual Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Italy, Netherlands, United States

Administrative Information

• NCT Number: NCT01694277
• Other Study ID Numbers: AB11002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AB Science
• Study Sponsor: AB Science
• Collaborators: Not Provided

Investigators

• Principal Investigator: Axel Le Cesne, M.D., Ph.D; Institute Gustave Roussy

• PRS Account: AB Science
• Verification Date: December 2020