CompletedPhase 1 / Phase 2NCT01045421

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

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.

Checked against the public recordLast updated Aug 15, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations2
SponsorMillennium Pharmaceuticals, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Millennium Pharmaceuticals, Inc.
Interventions being studied
Drug: MLN8237 (Alisertib)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Study locationHouston, Texas
  • Study locationSalt Lake City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 15, 2016. Always confirm current availability with the study team.

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