Clinical trial · Interventional
MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma
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
NCT00853307CI-TRIAL-00057682completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alisertib | Drug | Alisertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alisertib 50 mg
- description
- Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
- interventionNames
- Drug: Alisertib
Primary outcomes (1)
- measure
- Combined Best Overall Response Rate Based on Investigator Assessment
- timeFrame
- Every 2 cycles up to 12 months until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU)-every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
- description
- Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of \> 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.