Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Cogent Biosciences, Inc. (Voir sur ClinicalTrials)
avril 2022
septembre 2026
10 mai 2025
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination
with sunitinib. This is a multi-part study that will enroll approximately 442 patients.
Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of
CGT9486 to be used in subsequent parts in approximately 20 patients who have received at
least one prior line of therapy for GIST and 2) evaluating the potential for drug-drug
interactions between CGT9486 and sunitinib in approximately 18 patients who have received
at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the
study will enroll approximately 388 patients who are intolerant to, or who failed prior
treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to
sunitinib alone with patients being randomized in a 1:1 manner. Additionally, a drug-drug
interactions substudy will investigate the potential for CGT9486 to be a CYP3A4 inducer
in approximately 16 patients who have received at least one prior line of therapy for
GIST.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Axel LE CESNE | 08/04/2024 07:25:09 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - Hôpital de la Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Centre Eugene Marquis - 35042 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse - Hospital Rangueil - 31400 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| ICO St-Herblain - 44800 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. 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.
2. Documented disease progression on or intolerance to imatinib
3. Subjects must have received the following treatment:
DDI Substudy/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
4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part
2)
5. ECOG - 0 to 2
6. Have clinically acceptable local laboratory screening results (clinical chemistry
and hematology) within certain limits
Key
1. 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.
2. Documented disease progression on or intolerance to imatinib
3. Subjects must have received the following treatment:
DDI Substudy/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
4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part
2)
5. ECOG - 0 to 2
6. Have clinically acceptable local laboratory screening results (clinical chemistry
and hematology) within certain limits
Key
1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency
2. Clinically significant cardiac disease
3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study
drug
4. Gastrointestinal abnormalities including, but not limited to, significant nausea and
vomiting, malabsorption, external biliary shunt, or significant bowel resection that
would preclude adequate absorption
5. Any active bleeding excluding hemorrhoidal or gum bleeding
6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or
hepatitis C virus (HCV) antibody.
7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
8. Received strong CYP3A4 inhibitors or inducers
9. Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)