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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.

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Trial Profile

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 of Trial: Phase I/II

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Alisertib (Primary)
  • Indications Advanced breast cancer; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Oesophageal cancer; Small cell lung cancer; Solid tumours
  • Focus Adverse reactions; Biomarker; Therapeutic Use
  • Sponsors Millennium; Takeda Oncology

Most Recent Events

  • 11 Sep 2017 Results (n=671) of population PK analysis using patient data from 6 Phase 1, 1 Phase 1/2 and 3 Phase 2 clinical trials published in the British Journal of Clinical Pharmacology
  • 14 Dec 2013 Phase II results for breast cancer patients presented at the 36th Annual San Antonio Breast Cancer Symposium.
  • 28 Jun 2013 Planned end date changed from 1 Nov 2013 to 1 Jul 2013 as reported by ClinicalTrials.gov.

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