Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Millennium Pharmaceuticals, Inc.
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.
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)
You may not be if
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
Clareo Health | Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies
