Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies
Completed · Phase 1/Phase 2
Conditions studied: Advanced Nonhematological Malignancies, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Metastatic Breast Cancer, Head and Neck Squamous Cell Carcinoma, Gastroesophageal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT01045421
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 273
- Starts
- 2010-02-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2016-08-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- 18 years or older
- Histologically or cytologically confirmed metastatic and/or advanced solid tumor (Phase 1 only)
- Phase 2 requires Non-small cell lung cancer (NSCLC); Small-cell lung cancer; Breast adenocarcinoma (female patients only); Squamous cell cancer of the head and neck (HNSCC); or Gastroesophageal adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
- Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
- Voluntary written consent
- Wiling to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
- Measurable disease (Phase 2 only)
You may not qualify if…
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are pregnant or lactating
- Serious medical or psychiatric illness that could interfere with protocol completion
- Receipt of more than 2 previous cytotoxic chemotherapeutic regimens (4 previous regimens for breast cancer). There is no limit on the number of prior noncytotoxic therapies
- Prior treatment with Aurora A-targeted agents, including MLN8237
- Prior treatment with high-dose chemotherapy
- Prior allogeneic bone marrow or other organ transplant
- Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior to first dose of MLN8237
- Symptomatic brain metastasis
- Radiotherapy to greater than 25% of bone marrow
- Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
- Myocardial infarction within 6 months of enrollment
- Uncontrolled cardiovascular condition
- Major surgery within 14 days of first dose of MLN8237
- Active infection requiring systemic therapy, or other serious infection
- Inability to swallow oral medication
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- Patients requiring full systemic anticoagulation
- History of uncontrolled sleep apnea syndrome
- Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 and during the study
Where it is running
- Study site — Houston, Texas, United States
- Study site — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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