Trial · NCT02278783
Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer
NCT02278783, Phase 2, Terminated, University of Utah; results first posted 2016-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer. Trials, record NCT02278783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02278783
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer
- NCT number
- NCT02278783
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- regorafenib
- First posted
- 2014-10-30
- Last updated
- 2017-10-06
- Results first posted
- 2016-12-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6 Month Progression Free Survival (PFS) | Patients will be checked for PFS after 6 months on treatment | To evaluate the anti-tumor activity of Regorafenib as measured by progression free survival at 6 months in patients with recurrent gynecological cancers |
| Primary | Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Patients will remain on treatment for approximately 4-6 months on average. | To determine the nature and degree of toxicity of Regorafenib in this cohort of patients. Toxicity will be summarized by attribution: regorafenib-related adverse events grade 2 or higher will be reported. |
| Secondary | Estimate Progression Free Survival | At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months | To estimate progression free survival for patients treated with this regimen |
| Secondary | Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response) | Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months | To determine the frequency of clinical benefit (stable disease, partial, and complete response) according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6 Month Progression Free Survival (PFS) | Patients will be checked for PFS after 6 months on treatment | participants | NUMBER | |
| PRIMARY | Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Patients will remain on treatment for approximately 4-6 months on average. | participants | NUMBER | |
| SECONDARY | Estimate Progression Free Survival | At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months | Study was terminated early, no analysis performed. | ||
| SECONDARY | Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response) | Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months | Study was terminated early, no analysis performed. |
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 |
|---|---|---|---|---|---|
| 6 Month Progression Free Survival (PFS) | All Patients | 1 | participants | ||
| Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | All Patients | 1 | 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 | All Patients | 1 | |
| Overall Study | COMPLETED | All Patients | 1 | |
| Overall Study | NOT COMPLETED | All Patients | 0 |
Source ClinicalTrials.gov
Adverse events19
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 | All Patients | 1 | 1 | |
| other | tachycardia | Cardiac disorders | All Patients | 1 | 1 | |
| other | oral mucositis | Gastrointestinal disorders | All Patients | 1 | 1 | |
| other | diarrhea | Gastrointestinal disorders | All Patients | 1 | 1 | |
| other | chills | General disorders | All Patients | 1 | 1 | |
| other | platelet count decrease | Investigations | All Patients | 1 | 1 | |
| other | creatinine increased | Investigations | All Patients | 1 | 1 | |
| other | AST increased | Investigations | All Patients | 1 | 1 | |
| other | weight loss | Investigations | All Patients | 1 | 1 | |
| other | hyponatremia | Metabolism and nutrition disorders | All Patients | 1 | 1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | ||
| Total, other adverse events | All Patients | 1 | 1 |
| Total, serious adverse events | All Patients | 0 | 1 |
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/NCT02278783
GET https://conductscience.org/api/trials/v1/NCT02278783/registered