| Titre |
A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors |
| Protocole ID |
DESTINY-PanTumor02 |
| ClinicalTrials.gov ID |
NCT04482309 |
| Type(s) de cancer |
Tumeurs solides |
| Phase |
Phase II |
| Type étude |
Clinique |
| Médicament |
Trastuzumab Deruxtecan |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DE L'ENFANT-JESUS
1401 18e Rue, Québec, QC, G1J 1Z4
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Olivier Dumas
|
| Coordonnateur(trice) |
Marie-Pierre Brochu
418-525-4444 poste 15768
|
| Statut |
 Actif en recrutement |
| Date d'activation |
03-06-2024 |
| Critètes d'éligibilité |
- Locally advanced, unresectable, or metastatic disease based on most recent imaging.
-
The respective cohorts for patient inclusion are:
- Cohort 1: Biliary tract cancer
- Cohort 2: Bladder cancer
- Cohort 3: Cervical cancer
- Cohort 4: Endometrial cancer
- Cohort 5: Epithelial ovarian cancer
- Cohort 6: Pancreatic cancer
- Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.
- Progressed following prior treatment or who have no satisfactory alternative treatment option.
- Prior HER2 targeting therapy is permitted.
- HER2 expression for eligibility may be based on local or central assessment.
- Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
- Has protocol- defined adequate organ function including cardiac, renal and hepatic function.
|
| Critètes d'exclusion |
- Uncontrolled intercurrent illness
- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant severe illnesses
- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART
- Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
- Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.
|
Groupe d'étude en oncologie du Québec