MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma
Condition: Ovarian Carcinoma
MeSH terms: Carcinoma
Intervention: Alisertib
Intervention description: Alisertib capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female participants 18 years or older.

          2. Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or
             primary peritoneal carcinoma.

          3. Eastern Cooperative Oncology Group (ECOG) 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 Cancer
             antigen (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 or 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.