| TITRE |
Étude multicentrique de phase I/II sur l’innocuité, la pharmacocinétique et l’efficacité préliminaire d’APL-101 chez des sujets atteints d’un cancer du poumon non à petites cellules avec des mutations conduisant à un saut de l’EXON 14 de la protéine c-Met et tumeurs solides avancées avec dérégulation de la protéine c-Met |
| PROTOCOLE ID |
SPARTA |
| CLINICAL TRIAL.gov ID |
NCT03175224 |
| TYPE(S) DE CANCER |
Poumon non à petites cellules |
| PHASE |
Phase I-II |
| TYPE D'ÉTUDE |
Traitement |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Scott Owen
|
| COORDONATEUR(RICE) |
Corneille Bashagaluke
corneille.bashagaluke@muhc.mcgill.ca
514-934-1934 poste 34907
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN) Major Inclusion Criteria:
- Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
- For Phase 1, histologically and / or cytological confirmed unresectable or metastatic solid malignancy, refractory to standard therapies with no more than three prior lines of therapy.
- For Phase 2, five cohorts will be enrolled: Cohort A-1: NSCLC EXON 14 skip mutation (c-Met naïve) for first line treatment, Cohort A-2: NSCLC EXON 14 skip mutation (c-Met naïve) pretreated subjects with no more than 3 lines of prior therapy, Cohort B: NSCLC EXON 14 skip mutation (c-Met experienced; radiographic progression on prior c-Met inhibitor), Cohort C: basket of tumor types with c-Met high level amplification (NSCLC EXON 14 skip mutation excluded), Cohort D: basket of tumor type with c-Met fusions.
- Local/archival result (tissue and/or plasma) of a positive c-Met dysregulation is required
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- No chemotherapy treatments within at least 3 weeks prior to first dose of study treatment
- No planned major surgery within 4 weeks of first dose of APL-101
|
| CRITÈRES D'EXCLUSION |
(EN) Major Exclusion Criteria:
- Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
- Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
- History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
- Unable to swallow orally administered medication whole.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- Women who are breastfeeding.
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