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

M

Millennium Pharmaceuticals

Status and phase

Completed
Phase 2
Phase 1

Conditions

Gastroesophageal Adenocarcinoma
Small Cell Lung Cancer
Metastatic Breast Cancer
Advanced Nonhematological Malignancies
Head and Neck Squamous Cell Carcinoma
Non-Small Cell Lung Cancer

Treatments

Drug: MLN8237 (Alisertib)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01045421
2008-006981-27 (EudraCT Number)
U1111-1171-0859 (Registry Identifier)
C14007

Details and patient eligibility

About

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.

Full description

Following the determination of the Recommended Phase 2 Dose (RP2D) and schedule (Phase 1), 20 response-evaluable patients in each of the 5 tumor indications will be enrolled (Phase 2-Stage 1). An interim analysis will determine which tumor indications will proceed to enroll an additional 25 patients (Phase 2-Stage 2) to further evaluate Overall Response Rate (ORR) and other secondary endpoints.

Enrollment

273 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

273 participants in 1 patient group

MLN8237 (Alisertib)
Experimental group
Description:
MLN8237 administered as an enteric-coated tablet (ECT)
Treatment:
Drug: MLN8237 (Alisertib)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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