Trial · NCT02315430
Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02315430, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Trials, record NCT02315430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02315430
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- NCT number
- NCT02315430
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Fallopian Tube Clear Cell Adenocarcinoma, Ovarian Clear Cell Adenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Interventions
- Cabozantinib S-malate, Laboratory Biomarker Analysis
- First posted
- 2014-12-11
- Last updated
- 2020-03-10
- Results first posted
- 2020-03-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Patients Who Survive Progression Free for at Least 6 Months | Every 8 weeks during treatment, assessesd up to 6 months for progression free survival. | Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Primary | Objective Tumor Response | Every 8 weeks during treatment;assessed up to 20 months. | Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Number of Participants With Grade 3 or Higher Adverse Events | Every cycle while on treatment, up to 30 days after treatment ends, an average of 14 months. | Grade 3 or higher adverse events were graded by CTC AE v 4. |
| Secondary | Progression-free Survival | Tumor scan done every 8 weeks during treatment, Average progression free survival was 3.6 months. | Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1 |
| Secondary | Overall Survival | Every cycle during treatment, up to 20.1 months. | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Patients Who Survive Progression Free for at Least 6 Months | Every 8 weeks during treatment, assessesd up to 6 months for progression free survival. | Eligible and Treated Patients | percentage of participants | NUMBER |
| PRIMARY | Objective Tumor Response | Every 8 weeks during treatment;assessed up to 20 months. | Eligible and Treated Patients | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3 or Higher Adverse Events | Every cycle while on treatment, up to 30 days after treatment ends, an average of 14 months. | Eligible and Treated Patients | participants | NUMBER |
| SECONDARY | Progression-free Survival | Tumor scan done every 8 weeks during treatment, Average progression free survival was 3.6 months. | Eligible and Treated Patients | months | MEAN |
| SECONDARY | Overall Survival | Every cycle during treatment, up to 20.1 months. | Eligible and Treated Patients | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Patients Who Survive Progression Free for at Least 6 Months | Cabozantinib | 23 | 90% Confidence Interval 7 to 49 | percentage of participants | |
| Objective Tumor Response | Cabozantinib | 0 | 90% Confidence Interval 0 to 21 | percentage of participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Cabozantinib | Nausea | 3 | participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Cabozantinib | Vomiting | 3 | participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Cabozantinib | Thromboembolic Event | 3 | participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Cabozantinib | Fatigue | 2 | participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Cabozantinib | Dehydration | 2 | participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Cabozantinib | Dyspnea | 2 | participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Cabozantinib | Abdominal Pain | 1 | participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Cabozantinib | Diarrhea | 1 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cabozantinib | 13 | |
| Overall Study | COMPLETED | Cabozantinib | 13 | |
| Overall Study | NOT COMPLETED | Cabozantinib | 0 |
Source ClinicalTrials.gov
Adverse events92
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 | Anemia | Blood and lymphatic system disorders | Cabozantinib | 5 | 13 | |
| other | Ventricular Tachycardia | Cardiac disorders | Cabozantinib | 1 | 13 | |
| other | Chest Pain - Cardiac | Cardiac disorders | Cabozantinib | 1 | 13 | |
| other | Vertigo | Ear and labyrinth disorders | Cabozantinib | 1 | 13 | |
| other | Tinnitus | Ear and labyrinth disorders | Cabozantinib | 1 | 13 | |
| other | Hypothyroidism | Endocrine disorders | Cabozantinib | 3 | 13 | |
| other | Floaters | Eye disorders | Cabozantinib | 1 | 13 | |
| other | Dysphagia | Gastrointestinal disorders | Cabozantinib | 1 | 13 | |
| other | Dyspepsia | Gastrointestinal disorders | Cabozantinib | 2 | 13 | |
| other | Dry Mouth | Gastrointestinal disorders | Cabozantinib | 2 | 13 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cabozantinib | 1 | 13 |
| Total, other adverse events | Cabozantinib | 13 | 13 |
| Total, serious adverse events | Cabozantinib | 6 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT02315430
GET https://conductscience.org/api/trials/v1/NCT02315430/results?page=2