NCT00812240

A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment

Terminated Phase 3 Last updated 31 January 2023

What this trial tests

Phase 3 trial testing Masitinib in Gastrointestinal Stromal Tumors in 335 participants. Terminated before completion.

Timeline

1 January 2009

Primary endpoint
1 July 2018

1 July 2018

Quick facts

Lead sponsor	AB Science
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	335
Start date	1 January 2009
Primary completion	1 July 2018
Estimated completion	1 July 2018
Sites	41 locations across United States, France, Lebanon

Drugs / interventions tested

• Masitinib — full drug profile →
• Imatinib — full drug profile →

Conditions studied

• Gastrointestinal Stromal Tumors — all drugs for Gastrointestinal Stromal Tumors →

Sponsor

AB Science — full company profile →

Who can join

18 and older, any sex, with Gastrointestinal Stromal Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression Free Survival (PFS)
  Time frame: From day of randomization to disease progression or death, assessed for a maximum of 96 months]
  Progression Free Survival is defined as the time from randomization to first documentation of objective tumor progression (date of tumor assessment documenting progressive disease assessed by CT Scan according to RECIST 1.1 and based on central review) or to death due to any cause (whichever comes first).

Sponsor's own description

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting fibroblast growth factor pathways in prostate cancer.
   Corn PG, Wang F, McKeehan WL, Navone N. · · 2013 · cited 87× · PMID 24052019 · DOI 10.1158/1078-0432.ccr-13-1550
2. Recent advances in the treatment of gastrointestinal stromal tumors.
   Serrano C, George S. · · 2014 · cited 46× · PMID 24790651 · DOI 10.1177/1758834014522491
3. Current and emerging strategies for the management of imatinib-refractory advanced gastrointestinal stromal tumors.
   Kee D, Zalcberg JR. · · 2012 · cited 40× · PMID 22942908 · DOI 10.1177/1758834012450935
4. c-Kit expression, angiogenesis, and grading in canine mast cell tumour: a unique model to study c-Kit driven human malignancies.
   Patruno R, Marech I, Zizzo N, Ammendola M, et al · · 2014 · cited 30× · PMID 24900982 · DOI 10.1155/2014/730246
5. Emerging Agents for the Treatment of Advanced, Imatinib-Resistant Gastrointestinal Stromal Tumors: Current Status and Future Directions.
   Bauer S, Joensuu H. · · 2015 · cited 27× · PMID 26187774 · DOI 10.1007/s40265-015-0440-8
6. Gastrointestinal stromal tumors: management of metastatic disease and emerging therapies.
   Vadakara J, von Mehren M. · · 2013 · cited 25× · PMID 24093167 · DOI 10.1016/j.hoc.2013.07.007
7. Recent advances and novel agents for gastrointestinal stromal tumor (GIST).
   Lamba G, Ambrale S, Lee B, Gupta R, et al · · 2012 · cited 23× · PMID 22569033 · DOI 10.1186/1756-8722-5-21
8. New systemic therapy options for advanced sarcomas.
   van der Graaf WT, Gelderblom H. · · 2012 · cited 16× · PMID 22661203 · DOI 10.1007/s11864-012-0196-2