| TITRE |
(EN) A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS) |
| PROTOCOLE ID |
KCP-330-020 |
| CLINICAL TRIAL.gov ID |
NCT02606461 |
| TYPE(S) DE CANCER |
Sarcome |
| PHASE |
Phase II-III |
| TYPE D'ÉTUDE |
Traitement |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Thierry Alcindor
|
| COORDONATEUR(RICE) |
Caroline Buote
caroline.buote@muhc.mcgill.ca
514-934-1934 poste 26215
|
| STATUT |
Fermé
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Patients ≥12 years of age
- Body surface area (BSA) ≥ 1.2 m2
- Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment
- Must have measurable disease per RECIST v1.1 Response Criteria
- Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy
- Must have had at least two (2) prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)
- If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug - whichever is shorter) with all clinically significant therapy- related toxicities having resolved to less than or equal to Grade 1
|
| CRITÈRES D'EXCLUSION |
(EN)
- Patients with pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes.
- Known active Hepatitis B (HepB), Hepatitis C (HepC) or human immunodeficiency virus (HIV) infection.
- Known central nervous system metastases
|
