Titre |
A phase 1A/B open-label master study of PF-07799544 as a single-agent and in combination with other targeted agents in participants with advanced solid tumors |
Protocole ID |
C4901001 |
ClinicalTrials.gov ID |
NCT05538130 |
Type(s) de cancer |
Tumeurs solides |
Phase |
Phase I |
Type étude |
Clinique |
Médicament |
PF-07799544 |
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) |
Geneviève Rochette
418-525-4444 poste 67540
|
Statut |
Actif en recrutement |
Date d'activation |
10-07-2023 |
Critètes d'éligibilité |
- Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
- Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
- For Substudy A and B, histological or cytological diagnosis of advanced/metastatic melanoma
- For Substudy A and B, measurable disease by RECIST version 1.1
- For Substudy A, evidence of a BRAF V600 mutation in tumor tissue and/or blood
- For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II alteration in tumor tissue and/or blood
|
Critètes d'exclusion |
- Brain metastasis larger than 4 cm
- Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
- For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
|