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

AB Science

Status and phase: Terminated; Phase 3

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: Masitinib; Drug: Imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812240

AB04030

Details and patient eligibility

About

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

Full 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. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

Enrollment: 335 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria include:

• Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST
• Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
• c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative

Main exclusion criteria include:

• Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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335 participants in 4 patient groups

Masitinib (7.5)

Experimental group

Description:

Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.

Treatment:

Drug: Masitinib

Masitinib (6.0)

Experimental group

Description:

Participants receive masitinib (6.0 mg/kg/day), given orally twice daily

Treatment:

Drug: Masitinib

Active Comparator (7.5)

Active Comparator group

Description:

Participants receive imatinib at 400 or 600 mg per day

Treatment:

Drug: Imatinib

Active Comparator (6.0)

Active Comparator group

Description:

Participants receive imatinib at 400 or 600 mg per day

Treatment:

Drug: Imatinib