Trial · NCT05113368
Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer
NCT05113368, Phase 2, Recruiting, Sarah K. Lynam MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer. Trials, record NCT05113368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05113368
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer
- NCT number
- NCT05113368
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 31 participants, estimated
- Lead sponsor
- Sarah K. Lynam MD
- Conditions
- Ovarian Cancer, Serous Ovarian Cancer
- Interventions
- Regorafenib, Fulvestrant
- First posted
- 2021-11-09
- Last updated
- 2025-08-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate of the Drug Regimen | 12 weeks from first cycle of treatment (each cycle is 28 days) | To assess the efficacy of this regimen in term of overall objective response rate (complete response rate) at 12 weeks as assessed by the Investigator, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). The number of participants that reach a complete response (CR) defined as normalization of tumor markers, tumor nodes \<10 mm. |
| Primary | Partial Response Rate of the Drug Regimen | 12 weeks from first cycle of treatment (each cycle is 28 days) | To assess the efficacy of this regimen in term of overall objective response rate (partial response rate) at 12 weeks as assessed by the Investigator, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). The number of participants that reach a partial response (PR)defined as at least a 30% decrease in the sum of diameters of target lesions. |
| Secondary | Overall Survival in Months | up to 3 years from start of study | To assess overall survival in months from enrollment to date of last follow up or death. The number of participants still alive at end of study. |
| Secondary | Progression-free Survival in Months | up to 3 years from start of study | To assess progression-free survival in months from enrollment to date of documented disease progression or death. The number of participants still alive at end of study. |
| Secondary | Clinical Benefit Rate | 12 weeks | To assess clinical benefit rate (objective response and stable disease)at 12 weeks. |
| Secondary | Assess Toxicity of this Combined Regime | at 3 months after treatment | The number of participants that have grade 3 and 4 related toxicities. Adverse Events will be characterized by type, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v.5.03), timing, seriousness, and relationship to study therapy. |
| Other | Identify genomic related markers | up to 3 years from start of study | Translational research component to identify genomic related markers that can predict response and/or resistance to the combined therapy. Archival tumor tissue will be utilized as baseline. Peripheral blood will be obtained at time of start of treatment (baseline), C2D1 (4 weeks), C3D1 (8 weeks), and C4D1 (12 weeks) and at time of progression. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05113368
GET https://conductscience.org/api/trials/v1/NCT05113368/registered