Titre |
A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor |
Protocole ID |
DCC-3014-01-001 |
ClinicalTrials.gov ID |
NCT03069469 |
Type(s) de cancer |
Tumeurs solides |
Phase |
Phase I-II |
Stade |
Maladie avancée ou métastatique |
Type étude |
Clinique |
Médicament |
DCC-3014 |
Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Thierry Alcindor
|
Coordonnateur(trice) |
Henry Nchienzia
514-934-1934 poste 34616
|
Statut |
Fermé |
Critètes d'éligibilité |
Dose Escalation Phase:
- Patients ≥18 years of age
-
Patients must have:
- advanced malignant solid tumors; or
- symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
- Malignant solid tumor patients only: Able to provide a tumor tissue sample
- Must have 1 measurable lesion according to RECIST Version 1.1
- Malignant solid tumor patients only: Must have ECOG performance status of 0-1
- Adequate organ and bone marrow function
- If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
- Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
Expansion Phase (Cohorts A and B)
- Patients ≥18 years of age
-
Patients must have symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
a) Expansion Cohort B: patients must have prior systemic treatment with anti-CSF1 or anti-CSF1R therapy, with the exception of imatinib or nilotinib
- Adequate organ and bone marrow function
- Must have at least 1 measurable lesion according to RECIST Version 1.1
- If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
- Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
|
Critètes d'exclusion |
Dose Escalation Phase:
- Received anticancer therapy or therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life (t1/2) longer than 3 days prior to the administration of study drug.
- Unresolved toxicity (Grade >1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia.
- Known active CNS metastases.
- History or presence of clinically relevant cardiovascular abnormalities.
- Systemic arterial or venous thrombotic or embolic events.
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome.
- Left ventricular ejection fraction (LVEF) <50%.
- Concurrent treatment with proton-pump inhibitor(s).
- Major surgery within 2 weeks of the first dose of study drug.
- Malabsorption syndrome or other illness that could affect oral absorption.
- Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection.
- If female, the patient is pregnant or lactating.
- Known allergy or hypersensitivity to any component of the study drug.
- Any other clinically significant comorbidities.
Expansion Phase (Cohorts A and B)
- Expansion Cohort A: received systemic therapy targeting CSF1 or CSF1R; previous therapy with imatinib and nilotinib is allowed.
- Expansion Cohort B: discontinued systemic therapy targeting anti-CSF1 or anti-CSF1R due to drug-induced liver injury.
- Treatment with therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with a t1/2 longer than 3 days prior to the administration of the study drug.
- Known metastatic TGCT or other active cancer that requires concurrent treatment.
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome.
- Left ventricular ejection fraction (LVEF) <55%.
- Concurrent treatment with proton-pump inhibitor(s).
- Major surgery within 2 weeks of the first dose of study drug.
- Any clinically significant comorbidities
- Malabsorption syndrome or other illness that could affect oral absorption.
- Known human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or active mycobacterium tuberculosis infection.
- If female, the patient is pregnant or lactating.
- Known allergy or hypersensitivity to any component of the study drug.
- Contraindication for MRI
- Active liver or biliary disease, including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis
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