| Titre |
A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors |
| Protocole ID |
Peak |
| ClinicalTrials.gov ID |
NCT05208047 |
| Type(s) de cancer |
Tumeur stromale gastro-intestinale |
| Phase |
Phase III |
| Médicament |
CGT9486+Sunitinib versus sunitinib |
| Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
 PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Jonathan Noujaim
|
| Coordonnateur(trice) |
Samara Bloom
514-252-3400 poste 6244
|
| Statut |
 Actif en recrutement |
| Date d'activation |
29-09-2023 |
| Critètes d'éligibilité |
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.
- Documented disease progression on or intolerance to imatinib
-
Subjects must have received the following treatment:
- Part 1a: Treatment with ≥1 prior lines of therapy for GIST
- Part 1b: Treatment with ≥2 prior TKI for GISTs
- Part 2: Prior treatment with imatinib only
- Have at least 1 measurable lesion according to mRECIST v1.1
- ECOG - 0 to 2
- Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
|
| Critètes d'exclusion |
- Known PDGFR driving mutations or known succinate dehydrogenase deficiency
- Clinically significant cardiac disease
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
- Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
- Any active bleeding excluding hemorrhoidal or gum bleeding
- Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
- Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
- Received strong CYP3A4 inhibitors or inducers
- Received sunitinib within 3 weeks (Part 1a, Part 1b)
|
Groupe d'étude en oncologie du Québec