Trial · NCT00853307
MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma
NCT00853307, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2018-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma. Trials, record NCT00853307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853307
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma
- NCT number
- NCT00853307
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Ovarian Carcinoma
- Interventions
- Alisertib
- First posted
- 2009-03-02
- Last updated
- 2022-04-08
- Other registries' IDs
- eudract:2008-006979-72
- Results first posted
- 2018-03-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Combined Best Overall Response Rate Based on Investigator Assessment | 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 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). |
| Secondary | Progression Free Survival (PFS) | 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 assessment that is stable disease (SD) or better. |
| Secondary | Duration Of Response (DOR) | 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) | DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions. |
| Secondary | Time To Progression (TTP) | 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) | TTP is defined as the time in days from the date of first study drug administration to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions. |
| Secondary | Clinical Benefit Rate | 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. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
| Secondary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events | 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. |
| Secondary | Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Combined Best Overall Response Rate Based on Investigator Assessment | 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) | Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level \> 40 units/milliliter (mL) and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | 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) | Response-evaluable population is defined as all participants who have measurable neoplastic disease according to RECIST criteria OR participants with CA 125 level \> 40 units/mL and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment. | days | MEDIAN |
| SECONDARY | Duration Of Response (DOR) | 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) | Due to study termination, there was insufficient data to perform this analysis. | ||
| SECONDARY | Time To Progression (TTP) | 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) | Due to study termination, there was insufficient data to perform this analysis. | ||
| SECONDARY | Clinical Benefit Rate | 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) | Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level \> 40 units/mL and clinical evidence of neoplastic disease and receive at least 1 dose of alisertib and have at least 1 post-baseline response assessment | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | First dose to 30 days past last dose (Up to 18.9 Months) | Safety Population is defined as all participants who received any amount of alisertib. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events | 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) | Safety Population is defined as all participants who received any amount of alisertib. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events | Baseline, Cycle 1 Days 8 and 15, then Every cycle Days 1, 8 and 15 to End of Treatment Up to 18.0 Months | Safety Population is defined as all participants who received any amount of alisertib. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Combined Best Overall Response Rate Based on Investigator Assessment | Alisertib 50 mg (Platinum-Refractory) | 0 | percentage of participants | ||
| Combined Best Overall Response Rate Based on Investigator Assessment | Alisertib 50 mg (Platinum-Resistant) | 12 | percentage of participants | ||
| Progression Free Survival (PFS) | Alisertib 50 mg (Platinum-Refractory) | 36.5 | 95% Confidence Interval 23.0 to 120.0 | days | |
| Progression Free Survival (PFS) | Alisertib 50 mg (Platinum-Resistant) | 77.0 | 95% Confidence Interval 43.0 to 122.0 | days | |
| Clinical Benefit Rate | Alisertib 50 mg (Platinum-Refractory) | 0 | percentage of participants | ||
| Clinical Benefit Rate | Alisertib 50 mg (Platinum-Resistant) | 32 | percentage of participants | ||
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | Alisertib 50 mg (Platinum-Refractory) | AE | 6 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | Alisertib 50 mg (Platinum-Resistant) | AE | 24 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | Alisertib 50 mg (Platinum-Refractory) | SAE | 4 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | Alisertib 50 mg (Platinum-Resistant) | SAE | 7 | participants |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alisertib 50 mg (Platinum-Refractory) | 6 | |
| Overall Study | STARTED | Alisertib 50 mg (Platinum-Resistant) | 25 | |
| Overall Study | COMPLETED | Alisertib 50 mg (Platinum-Refractory) | 4 | |
| Overall Study | COMPLETED | Alisertib 50 mg (Platinum-Resistant) | 20 | |
| Overall Study | NOT COMPLETED | Alisertib 50 mg (Platinum-Refractory) | 2 | |
| Overall Study | NOT COMPLETED | Alisertib 50 mg (Platinum-Resistant) | 5 |
Source ClinicalTrials.gov
Adverse events192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Refractory) | 3 | 6 | |
| other | Diarrhoea | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Resistant) | 14 | 25 | |
| other | Stomatitis | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Refractory) | 2 | 6 | |
| other | Stomatitis | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Resistant) | 13 | 25 | |
| other | Nausea | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Refractory) | 3 | 6 | |
| other | Nausea | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Resistant) | 11 | 25 | |
| other | Vomiting | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Refractory) | 4 | 6 | |
| other | Vomiting | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Resistant) | 8 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Refractory) | 2 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Alisertib 50 mg (Platinum-Resistant) | 8 | 25 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alisertib 50 mg (Platinum-Refractory) | ||
| Total, all-cause mortality | Alisertib 50 mg (Platinum-Resistant) | ||
| Total, other adverse events | Alisertib 50 mg (Platinum-Refractory) | 6 | 6 |
| Total, other adverse events | Alisertib 50 mg (Platinum-Resistant) | 24 | 25 |
| Total, serious adverse events | Alisertib 50 mg (Platinum-Refractory) | 4 | 6 |
| Total, serious adverse events | Alisertib 50 mg (Platinum-Resistant) | 7 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Alisertib 50 mg (Platinum-Refractory) vs Alisertib 50 mg (Platinum-Resistant): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00853307
GET https://conductscience.org/api/trials/v1/NCT00853307/results?page=2