Status:
COMPLETED
MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Ovarian Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 t...
Detailed Description
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00853307
Start Date
March 23 2009
End Date
January 27 2011
Last Update
April 8 2022
Active Locations (1)
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1
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922