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About
This is an open-label, multicenter study with a phase 1 dose escalation portion and a 2-stage, phase 2 portion, investigating MLN8237 (alisertib) in patients with advanced nonhematological malignancies.
Full description
Following the determination of the Recommended Phase 2 Dose (RP2D) and schedule (Phase 1), 20 response-evaluable patients in each of the 5 tumor indications will be enrolled (Phase 2-Stage 1). An interim analysis will determine which tumor indications will proceed to enroll an additional 25 patients (Phase 2-Stage 2) to further evaluate Overall Response Rate (ORR) and other secondary endpoints.
Enrollment
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Inclusion criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Primary purpose
Allocation
Interventional model
Masking
273 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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