Conditions: Advanced Nonhematological Malignancies Non-Small Cell Lung Cancer Small Cell Lung Cancer Metastatic Breast Cancer Head and Neck Squamous Cell Carcinoma Gastroesophageal Adenocarcinoma
Keywords: NSCLC SCLC HNSCC
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 273
Healthy volunteers: no

Brief 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.

Arms:
arm 1: MLN8237 administered as an enteric-coated tablet (ECT)

Interventions: intervention 1: MLN8237 (Alisertib)
Intervention descriptions: intervention 1: 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.

Protocol document: