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MLN8237 in Adults With Nonhematological Malignancies, Followed by MLN8237 in Lung, Breast, Head and Neck or Gastroesophageal Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01045421
First received: January 8, 2010
Last updated: January 10, 2014
Last verified: January 2014

January 8, 2010
January 10, 2014
February 2010
May 2013   (final data collection date for primary outcome measure)
  • Phase 1: To assess the safety and tolerability of MLN8237, formulated as an enteric-coated tablet (ECT), on a 7-day dosing schedule for determining the recommended dose and schedule to be used in Phase 2 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Phase 2: To estimate the antitumor activity of MLN8237 as measured by overall response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Phase 1: To assess the safety and tolerability of MLN8237, formulated as an enteric-coated tablet (ECT), on a 7- and 14-day dosing schedule for determining the recommended dose and schedule to be used in Phase 2 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Phase 2: To estimate the antitumor activity of MLN8237 as measured by overall response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01045421 on ClinicalTrials.gov Archive Site
  • Phase 1: To characterize the pharmacokinetics of MLN8237, formulated as ECT, administered on a 7-day dosing schedule and to describe any antitumor activity that may be observed with treatment in patients with advanced nonhematological malignancies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Phase 2: To assess the relationship between clinical response and molecular markers of response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Phase 2: To assess additional measures of antitumor activity, including time to progression, progression-free survival and duration of response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Phase 2: To characterize the safety profile associated with MLN8237 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Phase 1: To characterize the pharmacokinetics of MLN8237, formulated as ECT, administered on a 7-and 14-day dosing schedule and to describe any antitumor activity that may be observed with treatment in patients with advanced nonhematological malignancies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Phase 2: To assess the relationship between clinical response and molecular markers of response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Phase 2: To assess additional measures of antitumor activity, including time to progression, progression-free survival and duration of response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Phase 2: To characterize the safety profile associated with MLN8237 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
MLN8237 in Adults With Nonhematological Malignancies, Followed by MLN8237 in Lung, Breast, Head and Neck or Gastroesophageal Malignancies
A Phase 1 Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in Adult Patients With Nonhematological Malignancies, Followed by a Phase 2 of MLN8237 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 in patients with advanced nonhematological malignancies.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Nonhematological Malignancies
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Metastatic Breast Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Gastroesophageal Adenocarcinoma
Drug: MLN8237

Phase 1:

MLN8237 will be administered orally twice a day on a 7-day dosing schedule

Phase 2:

MLN8237 will be administered orally at the maximum tolerated dose determined in Phase 1 for 7-days followed by a minimum 14-day rest period.

Experimental: MLN8237
MLN8237 administered as an enteric-coated tablet (ECT)
Intervention: Drug: MLN8237
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
273
July 2014
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01045421
C14007, 2008-006981-27
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP