MLN8237 for Treatment of Patients With Ovarian, Fallopian Tube, or Peritoneal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00853307
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Brief Summary:
This is an open-label, multicenter, single-arm, phase 2 study of MLN8237 in the treatment of patients with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Drug: MLN8237 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in the Treatment of Patients With Platinum-Refractory or Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Study Start Date : March 2009
Primary Completion Date : April 2010
Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: 1
Drug: MLN8237
MLN8237 will be given by mouth in a dosage of 50 mg twice a day for 7 Days (Days 1-7) of each 21-day treatment cycle.

Primary Outcome Measures :
  1. Combined objective response rate, defined as complete response + partial response by Response Evaluation Criteria in Solid Tumors criteria or response by CA 125 criteria [ Time Frame: CT or MRI every 2 cycles (6 weeks) to 12 months until progressive disease ]

Secondary Outcome Measures :
  1. Progression Free Survival, Duration Of Response, Time To Progression, and clinical benefit rate [ Time Frame: CT or MRI every 2 cycles up to 12 months until progressive disease is documented. Patients who discontinue study drug before progressive disease will be assessed at Follow-Up visits once every 12 weeks up to 12 months, until progressive disease or other ]
  2. Adverse events, serious adverse events, assessments of clinical laboratory values, and vital signs measurements [ Time Frame: Clinical exam prior to every cycle (21 days); safety labs weekly ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female patients 18 years or older
  2. Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  3. Eastern Cooperative Oncology Group performance status 0 or 1
  4. 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
  5. Able to provide written informed consent.
  6. Within 7 days before study:

    • Absolute neutrophils (ANC) ≥ 1,500/μL
    • Platelets ≥100,000/ μL
    • Total bilirubin must be < 1.5 times upper limit of the normal (ULN)
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be ≤ 2.5 times the ULN. AST and ALT may be elevated up to 5 times the ULN if ascribed to metastatic liver disease.
    • Creatinine clearance ≥ 30 mL/minute
  7. Platinum-refractory or -resistant disease
  8. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) OR CA 125 level of > 40 units/mL AND clinical evidence disease
  9. Recovered from effects of prior therapy

Exclusion Criteria:

  1. Pregnant or lactating
  2. Serious illness that could interfere with protocol completion
  3. Investigational treatment 28 days prior to first dose.
  4. Maximum 4 prior systemic therapies: 2 platinum-based, 1 nonplatinum cytotoxic, 1 biological
  5. Known Central Nervous System metastases
  6. Prior allogeneic bone marrow or organ transplantation
  7. Radiotherapy within 21 days prior to first dose
  8. Radiotherapy to > 25% bone marrow
  9. Major surgery, infection requiring systemic antibiotic therapy within 14 days prior to first dose
  10. Inability to swallow orally administered medication
  11. 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
  12. Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00853307

United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT00853307     History of Changes
Other Study ID Numbers: C14006
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders