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CompletedPhase 1 / Phase 2NCT01045421
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMLN8237 (Alisertib)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Millennium Pharmaceuticals, Inc.

Study sponsor

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.

Cancer type
Non-small cell lung cancer (NSCLC)→Small cell lung cancer (SCLC)→
Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)
Reasons someone may not be able to joinExclusion criteria

Patients meeting any of the following

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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