18 and older, female only, with Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Combined Best Overall Response Rate Based on Investigator AssessmentPrimary· 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)
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 hav
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
12
Progression Free Survival (PFS)Secondary· Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: 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)
PFS is defined as the time in days from the date of first study drug administration to the date of first documented Progressive Disease (PD) or death. PD is defined as 20% increase in the sum of the longest diameter of target lesions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level \> 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. For a participant who has not progressed and has not died, PFS is censored at the last response asse
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
36.5
23.0 – 120.0
Alisertib 50 mg (Platinum-Resistant)
77.0
43.0 – 122.0
Clinical Benefit RateSecondary· Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: 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)
Clinical benefit rate is defined as the percentage of participants with response and stable disease (SD), where in order for SD to qualify as having clinical benefit, there must be no progression of neoplastic disease for at least 4 treatment cycles.
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
32
Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse EventsSecondary· First dose to 30 days past last dose (Up to 18.9 Months)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A
AE
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
6
Alisertib 50 mg (Platinum-Resistant)
24
SAE
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
4
Alisertib 50 mg (Platinum-Resistant)
7
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse EventsSecondary· Baseline, Cycle 1 Days 8 and 15, then Day 1 of every cycle (21 days), End of Treatment, End of Study/FU every 12 weeks for up to 12 months (Up to 22 Months)
Vital signs included blood pressure, pulse rate, and oral temperature collected throughout the study. . A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.
Pyrexia
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
2
Alisertib 50 mg (Platinum-Resistant)
6
Dyspnoea
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
4
Weight decreased
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
3
Tachycardia
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
2
Hypertension
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
2
Dyspnoea exertional
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
1
Bradycardia
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
1
Shock
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
1
Alisertib 50 mg (Platinum-Resistant)
0
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse EventsSecondary· Baseline, Cycle 1 Days 8 and 15, then Every cycle Days 1, 8 and 15 to End of Treatment Up to 18.0 Months
Laboratory tests included Hematology and Chemistry. Abnormal laboratory value were assessed as an AE if the value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Neutropenia
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
3
Alisertib 50 mg (Platinum-Resistant)
17
Anaemia
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
2
Alisertib 50 mg (Platinum-Resistant)
14
Leukopenia
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
1
Alisertib 50 mg (Platinum-Resistant)
11
Thrombocytopenia
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
1
Alisertib 50 mg (Platinum-Resistant)
8
Dehydration
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
1
Alisertib 50 mg (Platinum-Resistant)
7
Hypokalaemia
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
2
Alisertib 50 mg (Platinum-Resistant)
4
Alanine aminotransferase increased
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
6
Aspartate aminotransferase increased
Group
Value
95% CI
Alisertib 50 mg (Platinum-Refractory)
0
Alisertib 50 mg (Platinum-Resistant)
6
Adverse events — posted to ClinicalTrials.gov
Time frame: First dose of study drug to 30 past last dose of study drug (Up to18.9 Months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07465757 — A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
· Phase 2
· not yet recruiting
NCT06369285 — A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Meta
· Phase 2
· recruiting
NCT06095505 — A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
· Phase 2
· recruiting
NCT04555837 — Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer
· Phase 1, PHASE2
· completed
NCT04479306 — Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage I
· Phase 1
· completed
Other recruiting trials for Ovarian Carcinoma
Currently open trials in the same condition.
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· NA
· recruiting
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· NA
· recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
· Phase 2
· recruiting
NCT06964009 — DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer
· Phase 1
· recruiting
NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
· Phase 1
· recruiting
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Trials by the same sponsor.
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· completed
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· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 8 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00853307.