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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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