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

Completed · Phase 2

Conditions studied: Ovarian Carcinoma

In brief

The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in the treatment of participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.

Key facts

Study ID

NCT00853307

Run by

Millennium Pharmaceuticals, Inc.

People needed

31

Starts

2009-03-23

Expected to finish

2011-01-27

Last updated by the study team

2022-04-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female participants 18 years or older.
• Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• 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.
• 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
• Platinum-refractory or -resistant disease.
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) OR Cancer antigen (CA) 125 level of > 40 units/mL AND clinical evidence disease.
• Recovered from effects of prior therapy.

You may not qualify if…

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

Where it is running

• Summit Medical Group — Berkeley Heights, New Jersey, United States

Full record on ClinicalTrials.gov

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