Trial · NCT02466802
Study of Regorafenib and Sildenafil for Advanced Solid Tumors
NCT02466802, Phase 1, Completed, Virginia Commonwealth University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Regorafenib and Sildenafil for Advanced Solid Tumors. Trials, record NCT02466802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02466802
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Regorafenib and Sildenafil for Advanced Solid Tumors
- NCT number
- NCT02466802
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Solid Tumor
- Interventions
- Regorafenib, Sildenafil Citrate
- First posted
- 2015-06-09
- Last updated
- 2020-02-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the recommended phase 2 dose (RP2D) of the combination of regorafenib and of sildenafil when given to patients with advanced solid tumors. | 28 days | Patients' treatment dosing level, dose modification, DLTs, and evaluability for DLTs will be listed and summarized by basic descriptive statistics (such as frequency and proportion). The MTD/RP2D will be found based on the Definitions of Dose-Limiting Toxicity, Maximum Tolerated Dose, and Recommended Phase 2 Dose. RP2D for the combination of regorafenib and sildenafil that is less than or the same as the MTD. |
| Secondary | To evaluate the safety and toxicity of the regorafenib and sildenafil combination | Up to 30 days after completion of study treatment | Adverse events reported according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. Adverse events (AEs) characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) to determine safety and toxicity of the combination of regorafenib and sildenafil. |
| Secondary | To explore the antitumor effects of the regorafenib and sildenafil combination | Up to 30 days after completion of study treatment | Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) |
| Secondary | To determine the pre-treatment expression of phosphodiesterase type 5 (PDE5) in tumor samples | 12- 24 months | Pre-treatment PDE5 expression identified by immunohistochemistry using archived tumor tissue. Pre-treatment PDE5 expression identified by immunohistochemistry (IHC) using archived tumor tissue. |
| Secondary | To evaluate the impact of sildenafil on the pharmacokinetics of regorafenib | 12-24 months | Regorafenib plasma concentration measured at a total of 6 time points: at baseline (pre-treatment) and at 5 time points in cycle 1. Plasma concentration of regorafenib measured at 6 time points: at baseline (pre-treatment) and in cycle 1 on day 1 (post-treatment), on day 15 (pre- and post-treatment), and on day 21 (pre- and post-treatment) |
| Other | To explore the PD relationships between regorafenib and tumor response | 12-24 months | Quantity of total and free regorafenib measured by in vitro RAF-1 kinase activity inhibition using plasma samples collected at baseline (pre-treatment) and in cycle 1 (post-treatment on day 1, pre- and post-treatment on day 15, and pre- and post-treatment on day 21) |
| Other | To assess the feasibility of isolating, enumerating, and analyzing CTCs to characterize cGMP within tumor cells | Up to 30 days after completion of study treatment | Characteristics of cGMP found in CTCs isolated and enumerated using the ApoStream DEPfff enrichment device with blood samples collected at baseline (pre-treatment), on days 1 and 15 in cycle 1, and at the time of each tumor response assessment |
| Other | To assess the bioactivity of sildenafil in plasma | 12-24 months | Quantity of total sildenafil measured by elevated VASP-1 phosphorylation ex vivo using plasma samples collected at baseline (pre-treatment) and in cycle 1 (post-treatment on day 1, pre- and post-treatment on day 15, and pre- and post-treatment on day 21) |
| Other | To assess the cytokine/growth factor levels in plasma | Up to day 21 of course 1 | Quantity of cytokines/growth factors measured using a Bio-Rad MAGPIX multiplex reader ex vivo using plasma samples collected at baseline (pre-treatment) and in cycle 1 (post-treatment on day 1, pre- and post-treatment on day 15, and pre- and post-treatment on day 21) |
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02466802
GET https://conductscience.org/api/trials/v1/NCT02466802/registered