NCT01045421

Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies

A Phase 1 Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in Adult Patients With Nonhematological Malignancies, Followed by a Phase 2 of MLN8237 in Lung, Breast, Head and Neck, or Gastroesophageal Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Advanced Nonhematological Malignancies
• Non-Small Cell Lung Cancer
• Small Cell Lung Cancer
• Metastatic Breast Cancer
• Head and Neck Squamous Cell Carcinoma
• Gastroesophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	MLN8237 (Alisertib)	Phase 1: MLN8237 will be administered orally twice a day on a 7-day dosing schedule Phase 2: MLN8237 will be administered orally at the maximum tolerated dose determined in Phase 1 for 7-days followed by a minimum 14-day rest period.

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-05-01
• Completion: 2014-04-01
• First posted: 2010-01-11
• Last updated: 2016-08-15
• Results posted: 2016-08-15

Locations

2 sites across 1 country: United States