Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index. Multicenter, prospective, randomized study.

Phase 1

• Conditions: Patients with intermediate-risk gastrointestinal stromal tumor presenting a high Genomic Grade Index; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005255-87-FR
• Lead Sponsor: Assistance Publique Hôpitaux de MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-19
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Subject with no prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy
- Subject with a Performance Status between 0-2
- Subject with a gastrointestinal stromal tumor, intermediary risk from the Armed Forces Institute of
Pathology classification [Miettenen 2006]
- Subject with Genomic Grade Index higher than 10 determined by CGH array;
- Subject with surgery for primary tumor performed from 2 weeks to 2 months before starting adjuvant Imatinib mesylate;
- Subject with no evidence of residual macroscopic disease after surgery (RO). Microscopically infiltrated margins, or supposed to be are allowed (R1)
- Subjects with absence of distant metastases

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Subject under 18 years old or pregnant or breast-feeding women.
- Subject with a contraindication to Imatinib, a known hypersensitivity to the active substance or to any of
the excipients (ambivalence clause);
- Subject treated with medicinal products that induce CYP3A4;
- Subject who have experienced spontaneous tumor rupture before surgery (risk of spread);
- Subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from tumor block;
- Subject whose mutational status meets the wild phenotype definition as evidenced by sequencing from tumor block;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified