Solid TumorPhase 1NCT02466802
Study of Regorafenib and Sildenafil for Advanced Solid Tumors
A Phase 1 study testing Regorafenib and Sildenafil Citrate in people with Solid Tumor, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This is a phase 1 study of sildenafil in combination with regorafenib in patients with progressive advanced solid tumors. A modified 3+3 dose escalation design will be conducted for the dose escalation of the treatment combination: additional patients will be enrolled at the MTD until a total of 12 patients have been… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Regorafenib and Sildenafil Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 28 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced solid tumor that has progressed during or after treatment with approved therapies or for which there is no standard effective therapy available
- Note: patients with solid tumors for which regorafenib would be considered a standard treatment are eligible as long as regorafenib has not been previously administered
- Measurable or evaluable disease by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Platelets >= 100,000/mm^3
Show all 22Show fewer
- Hemoglobin > 9 g/dL (untransfused)
- Creatinine =< 1.5 x upper limit of normal (ULN) for the laboratory or calculated or actual creatinine clearance >= 60 mL/min
- Proteinuria =< grade 1 (ie, =< 1+ [30 mg/dL] using a random urine sample or < 1.0 gm using a 24-hour sample)
- Note: if urine sample indicates >= grade 2 proteinuria (ie, 2+ [100 mg/dL]), a 24-hour urine sample must be collected and tested; urine protein in the 24-hour sample must be < 1.0 gm/24 hours • Total bilirubin =< 1.5 x ULN for the laboratory
- Exception: if a patient has documented Gilbert's syndrome and a total bilirubin is > 1.5 x ULN, the total bilirubin requirement may be waived provided the direct bilirubin is within normal limits (WNL) for the laboratory
- Aspartate aminotransferase (AST) =< 2.5 x ULN for the laboratory
- Alanine aminotransferase (ALT) =< 2.5 x ULN for the laboratory
- Alkaline phosphatase =< 2.5 x ULN for the laboratory (=< 5 x ULN for patients with cancer involving the liver and/or bone)
- Non-hematologic toxicities from previous cancer therapies resolved to =< grade 1
- International normalized ratio (INR) is =< 1.5
- Activated partial thromboplastin time (aPTT) =< 1.5 x ULN for the laboratory
- Left ventricular ejection fraction (LVEF) assessed by echocardiogram within 3 months prior to initiation of study treatment indicates an LVEF of >= 50%
- A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment
- A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for 2 months following completion of study treatment
- Ability to understand and willingness to sign the consent form written in English
- Note: the consent form must be signed prior to the conduct of any trial-specific procedure
Who cannot join
- Meningeal metastases or brain metastases that are symptomatic or untreated * Note: patients who are asymptomatic and have had post-treatment imaging that indicates stable brain disease are eligible; (patients with meningeal metastasis are not eligible even if stable following treatment); also, note that brain imaging is required within 8 weeks prior to initiation of study therapy
- Any investigational agent within 4 weeks prior to initiating study treatment
- Previous therapy with regorafenib
- If sorafenib was previously administered, intolerance to sorafenib
- Inability to swallow medication
- Known or suspected malabsorption condition or obstruction
Show all 43Show fewer
- Contraindications to sildenafil including:
- Known retinitis pigmentosa
- History of priapism related to PDE5 inhibitors (eg, sildenafil, vardenafil, tadalafil)
- Presence of nonmalignant hematologic disorders, such as sickle cell disease, that may increase the risk of priapism
- Contraindication to antiangiogenic agents, including:
- Serious non-healing wound, non-healing ulcer, or bone fracture
- Major surgical procedure or significant traumatic injury within 4 weeks prior to initiating study treatment
- Pulmonary hemorrhage/bleeding event >= grade 2 within 12 weeks prior to initiating study treatment
- Any other hemorrhage/bleeding event >= grade 3 within 12 weeks prior to initiating study treatment
- History of organ allograft including corneal transplant
- Any documented history of thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism within 6 months prior to initiating study treatment
- Note: patients with a tumor-associated thrombus of locally-involved vessels should not be excluded from participating in the study
- Evidence of bleeding diathesis or coagulopathy
- Resting systolic blood pressure (BP) < 100 mmHg
- Hypertension defined as systolic BP >= 140 mmHg or diastolic BP >= 90 mmHg despite optimal medical management
- Active or clinically significant cardiac disease including any of the following:
- Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment
- Myocardial infarction within 6 months prior to initiating study treatment
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
- New York Heart Association (NYHA) class III or IV congestive heart failure
- Seizure disorder requiring medication
- Serious (ie, >= grade 3) uncontrolled infection
- Known human immunodeficiency virus (HIV) seropositivity
- Note: HIV testing is not required
- Chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
- Pleural effusion or ascites that causes respiratory compromise (ie, >= grade 2 dyspnea)
- Untreated or metastatic pheochromocytoma
- Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment, for example:
- Alpha 1-blockers
- Vasodilators, such as nitrates
- Other PDE5 inhibitors, eg, vardenafil, tadalafil
- Therapeutic anticoagulation with vitamin K antagonists (eg, warfarin), heparins and heparinoids, or direct thrombin inhibitors (DTIs) ** Note: prophylactic low-dose anticoagulation to maintain vascular access devices or low-dose daily aspirin for cardiac health is permitted
- Immunosuppressants such as tacrolimus, leflunomide or tofacitinib, roflumilast, pimecrolimus
- Note: administration of steroids as part of symptom management or for other supportive care purposes is permitted
- STRONG cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or STRONG CYP3A4 inducers ** Note: if such medications have been used, patients must have discontinued these agents >= 2 weeks prior to initiating study treatment
- Pregnancy or breastfeeding
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Phase I Study of Regorafenib and Sildenafil for Advanced Solid Tumors
This is a phase 1 study of sildenafil in combination with regorafenib in patients with progressive advanced solid tumors. A modified 3+3 dose escalation design will be conducted for the dose escalation of the treatment combination: additional patients will be enrolled at the MTD until a total of 12 patients have been treated at the MTD.
Read the detailed description
This study is a single-arm, open-label, phase 1 trial to determine the RP2D of the combination of regorafenib and sildenafil. Both study medications will be taken orally on days 1-21 of each 28-day cycle.
Using a modified 3+3 dose escalation design, 3-6 patients with an advanced solid tumor will be enrolled at each dose level. Additional patients will be enrolled at the MTD until a total of 12 patients have been treated at the MTD.
Eligible patients will have received available standard treatments. Patients with solid tumors for which regorafenib would be considered a standard treatment are eligible as long as regorafenib has not been previously administered.
Blood samples will be collected for correlative studies including PK, PD, and CTCs. Tumor samples archived from a previous biopsy or surgery will also be collected for correlative studies.
- Conditions
- Solid Tumor
- Being tested
- Regorafenib, Sildenafil Citrate
- Keywords
- Advanced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Also called Stivarga, 755037-03-7, BAY 73-4506
Combination of regorafenib and of sildenafil when given to patients with advanced solid tumors. Regorafenib Administration and Treatment Schedule. Regorafenib will be taken orally once daily for the first 21 days of each 28-day cycle. Regorafenib will not be taken on the last 7 days of each cycle. Patients will be instructed as follows: Take regorafenib once daily with a low fat meal that contains less than 30% fat. Take the regorafenib tablets at about the same time each day. Swallow the tablets whole.
Sildenafil CitrateDrug
Also called Viagra, SILDENAFIL, Revatio, 171599-83-0
Combination of regorafenib and of sildenafil when given to patients with advanced solid tumors.Sildenafil Administration and Treatment Schedule. Sildenafil will be taken orally once daily at the same time the regorafenib dose is taken for the first 21 days of each 28-day cycle. Sildenafil will not be taken on the last 7 days of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| A: regorafenib and sildenafil citrate | Experimental | Patients receive regorafenib and sildenafil citrate by mouth every day (PO QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Regorafenib; Drug: Sildenafil Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the recommended phase 2 dose (RP2D) of the combination of regorafenib and of sildenafil when given to patients with advanced solid tumors.
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.
Measured: 28 days
Secondary outcomes (4)
To evaluate the safety and toxicity of the regorafenib and sildenafil combination
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.
Measured: Up to 30 days after completion of study treatment
To explore the antitumor effects of the regorafenib and sildenafil combination
Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
Measured: Up to 30 days after completion of study treatment
To determine the pre-treatment expression of phosphodiesterase type 5 (PDE5) in tumor samples
Pre-treatment PDE5 expression identified by immunohistochemistry using archived tumor tissue. Pre-treatment PDE5 expression identified by immunohistochemistry (IHC) using archived tumor tissue.
Measured: 12- 24 months
To evaluate the impact of sildenafil on the pharmacokinetics of regorafenib
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)
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start1 Jul 2015
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Andrew S. Poklepovic, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466802
- Sponsor's protocol ID
- MCC-13-09812
- Other IDs
- HM20004297, NCI-2015-01101
- Status last verified
- Feb 2020
- First submitted
- 4 Jun 2015
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Poklepovic AS, Gordon SW, Kothadia S, McGuire WP, Thacker LR, Deng X, Tombes MB, Shrader E, Hudson D, Bandyopadhyay D, Ryan AA, Kmieciak M, Smith S, Dent P. A phase 1 study of regorafenib and sildenafil in adults with advanced solid tumors. Anticancer Drugs. 2024 Jun 1;35(5):450-458. doi: 10.1097/CAD.0000000000001584. Epub 2024 Mar 8.
PubMed 38452059Booth L, Roberts JL, Rais R, Cutler RE Jr, Diala I, Lalani AS, Hancock JF, Poklepovic A, Dent P. Neratinib augments the lethality of [regorafenib + sildenafil]. J Cell Physiol. 2019 Apr;234(4):4874-4887. doi: 10.1002/jcp.27276. Epub 2018 Sep 10.
PubMed 30203445
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Regorafenib and Sildenafil for Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02466802
- Acronym / sponsor ID
- MCC-13-09812
- Conditions
- Solid Tumor
- Keywords
- Advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study of sildenafil in combination with regorafenib in patients with progressive advanced solid tumors. A modified 3+3 dose escalation design will be conducted for the dose escalation of the treatment combination: additional patients will be enrolled at the MTD until a total of 12 patients have been treated at the MTD.
Detailed description
This study is a single-arm, open-label, phase 1 trial to determine the RP2D of the combination of regorafenib and sildenafil. Both study medications will be taken orally on days 1-21 of each 28-day cycle.
Using a modified 3+3 dose escalation design, 3-6 patients with an advanced solid tumor will be enrolled at each dose level. Additional patients will be enrolled at the MTD until a total of 12 patients have been treated at the MTD.
Eligible patients will have received available standard treatments. Patients with solid tumors for which regorafenib would be considered a standard treatment are eligible as long as regorafenib has not been previously administered.
Blood samples will be collected for correlative studies including PK, PD, and CTCs. Tumor samples archived from a previous biopsy or surgery will also be collected for correlative studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A: regorafenib and sildenafil citrate | Experimental | Drug: Regorafenib, Drug: Sildenafil CitratePatients receive regorafenib and sildenafil citrate by mouth every day (PO QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Advanced solid tumor that has progressed during or after treatment with approved therapies or for which there is no standard effective therapy available
- Note: patients with solid tumors for which regorafenib would be considered a standard treatment are eligible as long as regorafenib has not been previously administered
- Note: if urine sample indicates >= grade 2 proteinuria (ie, 2+ [100 mg/dL]), a 24-hour urine sample must be collected and tested; urine protein in the 24-hour sample must be < 1.0 gm/24 hours • Total bilirubin =< 1.5 x ULN for the laboratory
- Exception: if a patient has documented Gilbert's syndrome and a total bilirubin is > 1.5 x ULN, the total bilirubin requirement may be waived provided the direct bilirubin is within normal limits (WNL) for the laboratory
- Note: the consent form must be signed prior to the conduct of any trial-specific procedure
Key exclusion criteria (43 listed)
- Meningeal metastases or brain metastases that are symptomatic or untreated * Note: patients who are asymptomatic and have had post-treatment imaging that indicates stable brain disease are eligible; (patients with meningeal metastasis are not eligible even if stable following treatment); also, note that brain imaging is required within 8 weeks prior to initiation of study therapy
- Any investigational agent within 4 weeks prior to initiating study treatment
- Previous therapy with regorafenib
- If sorafenib was previously administered, intolerance to sorafenib
- Inability to swallow medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegorafenibAlso: Stivarga, 755037-03-7, BAY 73-4506Combination of regorafenib and of sildenafil when given to patients with advanced solid tumors. Regorafenib Administration and Treatment Schedule. Regorafenib will be taken orally once daily for the first 21 days of each 28-day cycle. Regorafenib will not be taken on the last 7 days of each cycle. Patients will be instructed as follows: Take regorafenib once daily with a low fat meal that contains less than 30% fat. Take the regorafenib tablets at about the same time each day. Swallow the tablets whole. | Drug | A: regorafenib and sildenafil citrate |
| Sildenafil CitrateAlso: Viagra, SILDENAFIL, Revatio, 171599-83-0Combination of regorafenib and of sildenafil when given to patients with advanced solid tumors.Sildenafil Administration and Treatment Schedule. Sildenafil will be taken orally once daily at the same time the regorafenib dose is taken for the first 21 days of each 28-day cycle. Sildenafil will not be taken on the last 7 days of each cycle. | Drug | A: regorafenib and sildenafil citrate |
Primary outcome
To determine the recommended phase 2 dose (RP2D) of the combination of regorafenib and of sildenafil when given to patients with advanced solid tumors.
Time frame: 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.
4 secondary outcomes
To evaluate the safety and toxicity of the regorafenib and sildenafil combination
Time frame: Up to 30 days after completion of study treatment
To explore the antitumor effects of the regorafenib and sildenafil combination
Time frame: Up to 30 days after completion of study treatment
To determine the pre-treatment expression of phosphodiesterase type 5 (PDE5) in tumor samples
Time frame: 12- 24 months
To evaluate the impact of sildenafil on the pharmacokinetics of regorafenib
Time frame: 12-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 38452059Poklepovic AS, Gordon SW, Kothadia S, McGuire WP, Thacker LR, Deng X, Tombes MB, Shrader E, Hudson D, Bandyopadhyay D, Ryan AA, Kmieciak M, Smith S, Dent P. A phase 1 study of regorafenib and sildenafil in adults with advanced solid tumors. Anticancer Drugs. 2024 Jun 1;35(5):450-458. doi: 10.1097/CAD.0000000000001584. Epub 2024 Mar 8.
- Derived from this study: PubMed 30203445Booth L, Roberts JL, Rais R, Cutler RE Jr, Diala I, Lalani AS, Hancock JF, Poklepovic A, Dent P. Neratinib augments the lethality of [regorafenib + sildenafil]. J Cell Physiol. 2019 Apr;234(4):4874-4887. doi: 10.1002/jcp.27276. Epub 2018 Sep 10.
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Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew S. Poklepovic, MD principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Regorafenib and Sildenafil Citrate in people with Solid Tumor, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the recommended phase 2 dose (RP2D) of the combination of regorafenib and of sildenafil when given to patients with advanced solid tumors. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02466802, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.