At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 273 enrolled
Drug / intervention
MLN8237 (Alisertib)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating MLN8237 (Alisertib) for Advanced Nonhematological Malignancies and 5 related conditions. Completed, enrolled 273 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Nonhematological Malignancies, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Metastatic Breast Cancer, Head and Neck Squamous Cell Carcinoma, Gastroesophageal Adenocarcinoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2010
Enrollment StartFeb 2010
Primary CompletionMay 2013
Study CompletionApr 2014
TodayJul 2026
First PostedJan 11, 2010
Enrollment StartFeb 1, 2010
Primary CompletionMay 1, 2013
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.5 years ago
Interventions
MLN8237 (Alisertib)drug
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.