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:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01045421
First received: January 8, 2010
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Millennium Pharmaceuticals, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 273 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MLN8237
MLN8237 administered as an enteric-coated tablet (ECT)
|
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. |
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045421
Locations
| United States, Connecticut | |
| Medical Oncology Hematology, Stamford Hospital | |
| Stamford, Connecticut, United States, 06902 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
| Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01045421 History of Changes |
| Other Study ID Numbers: | C14007, 2008-006981-27 |
| Study First Received: | January 8, 2010 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Millennium Pharmaceuticals, Inc.:
|
NSCLC SCLC HNSCC |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Breast Neoplasms Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Lung Neoplasms Small Cell Lung Carcinoma Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms, Cystic, Mucinous, and Serous Neoplasms by Site Breast Diseases Skin Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplasms, Squamous Cell |
ClinicalTrials.gov processed this record on May 19, 2013