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Clinical Trial Summary

This is an open-label, multicenter study with a phase 1 dose escalation portion and a 2-stage, phase 2 portion, investigating MLN8237 in patients with advanced nonhematological malignancies.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01045421
Study type Interventional
Source Millennium Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 2010
Completion date January 2014

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