Phase 2
N=31
MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma
Ovarian Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00853307 ↗Enrolled (actual)
31
Serious AEs
35.5%
Results posted
Mar 2018
Primary outcome: Primary: Combined Best Overall Response Rate Based on Investigator Assessment — 0; 12 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alisertib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Best Overall Response Rate Based on Investigator Assessment |
0; 12 | — |
| SECONDARY Progression Free Survival (PFS) |
36.5; 77.0 | — |
| SECONDARY Duration Of Response (DOR) |
— | — |
| SECONDARY Time To Progression (TTP) |
— | — |
| SECONDARY Clinical Benefit Rate |
0; 32 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events |
6; 24; 4; 7 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events |
2; 6; 0; 4; 0; 3 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events |
3; 17; 2; 14; 1; 11 | — |
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
- 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 40 units/mL AND clinical evidence disease.
- Recovered from effects of prior therapy.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00853307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.