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SCCA Gynecologic Cancer Clinical Trials

MLN8237 Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Breast Cancer (7527)
Randomized Phase 2 Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Preceded by a Phase 1 Portion in Patients with Ovarian or Breast Cancer
Status Conditions Phase Study ID
Closed Ovarian Cancer
Breast Cancer
Fallopian Cancer
Peritoneal Cancer
Phase I/II 7527
NCT01091428
Summary

This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly paclitaxel in adult female patients with advanced breast cancer (Phase 1 portion only) and recurrent ovarian cancer (both Phase 1 and Phase 2 portions).


Investigator
Barbara Ann Goff, MD
Location    
SCCA Network 206-288-7232 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Female patients 18 years or older
  • Previously treated, metastatic or locally recurrent malignancy with 1 of the following diagnoses, which has been confirmed histologically or cytologically: adenocarcinoma of the breast (Phase 1 only), recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Phase 1 and 2)
  • In the Phase 1 portion of the study, patients with breast cancer must have received treatment with at least 1 but no more than 4 prior chemotherapy regimens not including regimens received in the neoadjuvant and/or adjuvant setting
  • Patients with breast cancer must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • No antineoplastic therapy or radiotherapy within 3 weeks before enrollment (2 weeks for regimens with recovery expected within 7 to 14 days) and recovered from toxicities of prior therapy (except alopecia); the patient must have recovered from all treatment-related toxicities and must have evidence of PD or persistent disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow, liver and renal function
  • Postmenopausal at least 1 year, OR Surgically sterile, OR If childbearing potential, agree to 2 effective methods of nonhormonal contraception, or agree to completely abstain from heterosexual intercourse
  • Able to provide written informed consent
  • Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
  • Suitable venous access
Exclusions (conditions that would prevent participation in this study)

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Prior treatment with an Aurora A-targeted agent (including MLN8237)
  • Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 and during the study
  • Treatment with more than 4 cytotoxic chemotherapy regimens in the metastatic setting; prior therapy cannot include more than 2 prior taxane-containing regimens
  • Known hypersensitivity to Cremophor® EL, paclitaxel or its components
  • Prior history of ≥ Grade 2 neurotoxicity or any toxicity requiring discontinuation from taxane chemotherapy that is not resolved to ≤ Grade 1
  • Comorbid or unresolved toxicity that would preclude administration of weekly paclitaxel
  • Primary central nervous system malignancy or carcinomatous meningitis
  • Symptomatic brain metastasis
  • Inability to swallow oral medications or maintain a fast
  • History of hemorrhagic or thrombotic cerebrovascular event in past 12 months
  • Surgery within 3 weeks before study enrollment and not fully recovered
  • Diagnosis or treatment of another malignancy within 2 years preceding first dose of MLN8237 and have any evidence of residual disease except nonmelanoma skin cancer or in situ malignancy completely resected
  • Pregnant or lactating
  • Serious illness that could interfere with protocol completion
  • Investigational treatment 21 days prior to first dose of MLN8237
  • Prior allogeneic bone marrow or organ transplantation
  • Infection requiring systemic antibiotic therapy within 14 days prior to first dose of MLN8237
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
  • Radiotherapy to > 25% bone marrow or whole pelvic radiotherapy
  • Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids of H2 antagonists are allowed
Last Updated
May 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.