| Titre |
A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric Patients With Relapsed or Refractory Malignancies |
| Protocole ID |
M13-833 Venetoclax |
| ClinicalTrials.gov ID |
NCT03236857 |
| Type(s) de cancer |
Pédiatrique divers |
| Phase |
Phase I |
| Stade |
Maladie réfractaire |
| Type étude |
Traitement |
| Médicament |
Venetoclax |
| Institution |
CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Henrique Bittencourt
|
| Coordonnateur(trice) |
Linda Hershon
514-345-4931 poste 5899
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
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Participants must have relapsed or refractory cancer.
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Participants must have adequate hepatic and kidney function.
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Participants less than or equal to 16 years of age must have performance status of Lansky greater than or equal to 50 and participants greater than 16 years of age must have performance status of Karnofsky greater than 50%.
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Participants with solid tumors must have adequate bone marrow function
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For the fifth cohort during Part 2 Cohort Expansion, participants with solid tumors must have evidence of BCL-2 expression.
|
| Critètes d'exclusion |
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Participants with primary brain tumors or disease metastatic to the brain.
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For participants with leukemia, has overt central nervous system (CNS) disease (CNS 3 status).
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Participants who have received any of the following within the listed time frame, prior to the first dose of study drug
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Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days
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CAR-T infusion or other cellular therapy within 30 days
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Anticancer therapy including blinatumomab or chemotherapy, radiation therapy, targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter
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Steroid therapy for anti-neoplastic intent within 5 days
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Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)
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Participants who are less than 100 days post-transplant, or greater than or equal to 100 days post-transplant with active graft versus host disease (GVHD), or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug.
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Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy.
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Participants who have received the following within 7 days prior to the first dose of study drug:
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Strong and moderate Cytochrome P450 3A (CYP3A) inhibitors (Part 1 Dose Determination);
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Strong and moderate CYP3A inducers (Part 1 Dose Determination and Part 2 Cohort Expansion).
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Participants who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
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Participants who have active, uncontrolled infections.
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Participants with malabsorption syndrome or any other condition that precludes enteral administration.
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Groupe d'étude en oncologie du Québec