Trial · NCT01031381
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
NCT01031381, Phase 2, Completed, University of Pittsburgh; results first posted 2016-08-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer. Trials, record NCT01031381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01031381
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
- NCT number
- NCT01031381
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Interventions
- RAD001, bevacizumab
- First posted
- 2009-12-14
- Last updated
- 2016-08-30
- Results first posted
- 2016-08-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) at 6-months | Up to 36 months (data collection period for the cohort); Up to 6 months for participant | The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). |
| Secondary | Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) | Within 4 weeks (28 days) of study treatment initiation (baseline) | The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) at 6-months | Up to 36 months (data collection period for the cohort); Up to 6 months for participant | Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days | percentage of participants | NUMBER |
| SECONDARY | Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) | Within 4 weeks (28 days) of study treatment initiation (baseline) | Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days + imaging every 8-12 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) at 6-months | RAD001 + Bevacizumab | 28 | 95% Confidence Interval 16.67 to 42.71 | percentage of participants | |
| Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) | RAD001 + Bevacizumab | 4 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RAD001 + Bevacizumab | 59 | |
| Overall Study | COMPLETED | RAD001 + Bevacizumab | 50 | |
| Overall Study | NOT COMPLETED | RAD001 + Bevacizumab | 9 |
Source ClinicalTrials.gov
Adverse events162
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 | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | RAD001 + Bevacizumab | 7 | 50 | |
| other | Blood/Bone Marrow - Other (Specify, __) | Blood and lymphatic system disorders | RAD001 + Bevacizumab | 1 | 50 | |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | RAD001 + Bevacizumab | 1 | 50 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | RAD001 + Bevacizumab | 2 | 50 | |
| other | Lymphopenia | Blood and lymphatic system disorders | RAD001 + Bevacizumab | 3 | 50 | |
| other | Platelets | Blood and lymphatic system disorders | RAD001 + Bevacizumab | 4 | 50 | |
| other | Hemoglobin | Blood and lymphatic system disorders | RAD001 + Bevacizumab | 9 | 50 | |
| other | Supraventricular and nodal arrhythmia, Atrial fibrillation | Cardiac disorders | RAD001 + Bevacizumab | 1 | 50 | |
| other | Supraventricular and nodal arrhythmia, Sinus bradycardia | Cardiac disorders | RAD001 + Bevacizumab | 1 | 50 | |
| other | Cardiac Arrhythmia - Other (Specify, __) | Cardiac disorders | RAD001 + Bevacizumab | 2 | 50 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RAD001 + Bevacizumab | ||
| Total, other adverse events | RAD001 + Bevacizumab | 50 | 50 |
| Total, serious adverse events | RAD001 + Bevacizumab | 19 | 50 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01031381
GET https://conductscience.org/api/trials/v1/NCT01031381/events?page=2