Physician EducationPhase 4SMARTNCT02287025
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?
A Phase 4 study testing Regorafenib (Stivarga, BAY73-4506), iPAD application and Bayer specialist in people with Physician Education, run by Bayer at 17 sites in United States.
Trial summary
Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff) support and education on treatment discontinuation rates in the absence of progression in patients with metastatic colorectal cancer treated with regorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physician Education
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506), iPAD application and Bayer specialist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 17 sitesUnited States
- Study dates
- 11 Nov 2014to 8 Apr 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically-proven metastatic CRC for which the decision of treatment with regorafenib was made
- Previous treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy
- Male or female patients ≥ 18 years of age
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Signed informed consent obtained before any study specific procedure is performed.Patients must be able to understand and willing to sign the written ICF.
- Life expectancy of at least 12 weeks
Show all 19Show fewer
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
- Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferease (AST)
- ≤ 3.0 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)
- Alkaline phosphastase limit ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)
- Lipase ≤ 1.5 x the ULN
- Amylase ≤ 1.5 x the ULN
- Serum creatinine ≤ 1.5 x the ULN
- International normalized ratio (INR) ≤ 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant (e.g., heparin), will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care.
- Platelet count ≥ 100000 /mm3, hemoglobin (Hb) ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm3. Blood transfusion to meet the inclusion criteria will not be allowed.
- Estimated creatinine clearance (CLcr) ≥ 30 mL/min as calculated using the Cockroft-Gault (C-G) equation.
- Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment.
- Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration.
Who cannot join
- Unable to swallow oral medications.
- Prior use of regorafenib
- Previous assignment to treatment during this study. Patients permanently withdrawn from study participation will not be allowed to re-enter study.
- Uncontrolled hypertension (systolic blood pressure > 140 millimeters of mercury (mmHg) or diastolic pressure > 90 mmHg despite optimal medical management)
- Active or clinically significant cardiac disease including:
- Congestive heart failure - New York Heart Association (NYHA) > Class II
Show all 13Show fewer
- Active coronary artery disease
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
- Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
- Evidence or history of bleeding diathesis or coagulopathy, irrespective of severity
- Any hemorrhage or bleeding event > National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4 weeks prior to the start of study medication
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 month before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication)
- Previously untreated or concurrent cancer that is distinct in primary site or histology from colorectal cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Patients surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed.All cancer treatments must be completed at least 3 years prior to study entry (i.e.,signature date of the ICF).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Anaheim, California, 92801
Study site
Anniston, Alabama, 36207
Study site
Bristol, Virginia, 24201
Study site
Canton, Ohio, 44718
Study site
Columbia, Maryland, 21044
Study site
Fayetteville, North Carolina, 28304
Study site
Gettysburg, Pennsylvania, 17325
Study site
Houston, Texas, 77024
Study site
Kingsport, Tennessee, 37660
Study site
Lafayette, Indiana, 47905
Study site
Lake City, Florida, 32024
Study site
Orange, California, 92668
Study site
Portsmouth, Virginia, 23704
Study site
Skokie, Illinois, 60076
Study site
Skokie, Illinois, 60077
Study site
Tulsa, Oklahoma, 74146
Study site
Tyler, Texas, 75701
About this study
Official title: Does Physician Education Influence Side Effect Management and Does it Increase Time on Treatment in the Absence of Progression ? A Phase 4 Open-label Trial With Regorafenib in Metastatic Colorectal Cancer
Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff) support and education on treatment discontinuation rates in the absence of progression in patients with metastatic colorectal cancer treated with regorafenib. Intensified education and support will be provided through an application for iPad which has automatic links to grading, dose reduction and side effect management ,as well as, references for additional articles.
- Conditions
- Physician Education
- Being tested
- Regorafenib (Stivarga, BAY73-4506), iPAD application, Bayer specialist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib (Stivarga, BAY73-4506)Drug
Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
iPAD applicationOther
Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
Bayer specialistOther
The treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise.
| Study group | Role | What they receive |
|---|---|---|
| SMART | Experimental | Investigators were supported with enhanced drug-specific information via an iPad application (SMART). Receives: Drug: Regorafenib (Stivarga, BAY73-4506); Other: iPAD application |
| Standard of Care | Active comparator | Investigators were supported with standard prescribing information. Receives: Drug: Regorafenib (Stivarga, BAY73-4506); Other: Bayer specialist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death
Measured: Up to 1 year
Secondary outcomes (5)
Duration of Treatment
Measured: Up to 1 year
Dose Intensity as Percentage of Planned Dose
Dose level 0 (standard starting dose) @ 160mg po qd. Dose level - 1 @ 120 mg po qd. Dose level - 2 @ 80 mg po qd. This schedule reflects the FDA-approved dosing specified in the prescribing information.
Measured: Up to 1 year
Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension
Documented during visits as part of the interval history. All AEs will be reported in the CRF with a diagnosis, start/stop dates, action taken.
Measured: Up to 1 year
Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire
Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.
Measured: Up to 1 year
Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire
Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study start11 Nov 2014
- Primary completion26 Feb 2016
- Study completion8 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physician EducationStudies of the same condition, open and under way.
- More trials run by BayerThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287025
- Sponsor's protocol ID
- 17347
- Acronym
- SMART
- Status last verified
- Jul 2017
- First submitted
- 7 Oct 2014
- Last updated
- 19 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Physician Education Influence Side Effect Management and Does it Increase Time on Treatment in the Absence of Progression ? A Phase 4 Open-label Trial With Regorafenib in Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02287025
- Acronym / sponsor ID
- SMART / 17347
- Conditions
- Physician Education
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- 26 Feb 2016 (actual)
- Study completion
- 8 Apr 2016 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 19 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff) support and education on treatment discontinuation rates in the absence of progression in patients with metastatic colorectal cancer treated with regorafenib. Intensified education and support will be provided through an application for iPad which has automatic links to grading, dose reduction and side effect management ,as well as, references for additional articles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART | Experimental | Drug: Regorafenib (Stivarga, BAY73-4506), Other: iPAD applicationInvestigators were supported with enhanced drug-specific information via an iPad application (SMART). |
| Standard of Care | Active comparator | Drug: Regorafenib (Stivarga, BAY73-4506), Other: Bayer specialistInvestigators were supported with standard prescribing information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or cytologically-proven metastatic CRC for which the decision of treatment with regorafenib was made
- Previous treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy
- Male or female patients ≥ 18 years of age
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Signed informed consent obtained before any study specific procedure is performed.Patients must be able to understand and willing to sign the written ICF.
Key exclusion criteria (13 listed)
- Unable to swallow oral medications.
- Prior use of regorafenib
- Previous assignment to treatment during this study. Patients permanently withdrawn from study participation will not be allowed to re-enter study.
- Uncontrolled hypertension (systolic blood pressure > 140 millimeters of mercury (mmHg) or diastolic pressure > 90 mmHg despite optimal medical management)
- Active or clinically significant cardiac disease including:
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 |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506)Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off | Drug | SMART, Standard of Care |
| iPAD applicationInvestigators were supported with enhanced drug-specific information via an iPad application (SMART). | Other | SMART |
| Bayer specialistThe treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise. | Other | Standard of Care |
Primary outcome
Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death
Time frame: Up to 1 year
5 secondary outcomes
Duration of Treatment
Time frame: Up to 1 year
Dose Intensity as Percentage of Planned Dose
Time frame: Up to 1 year
Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension
Time frame: Up to 1 year
Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire
Time frame: Up to 1 year
Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Physician Education
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Not yet recruiting
Physician vs Artificial Intelligence Counseling Before Elective Cesarean Delivery: A Randomized Controlled Trial
Cesarean Section, Informed Consent
Not yet recruiting
Peer-Learning Versus Physician-Led POCUS Training for Nurse Practitioners in Integrative Volume Status Assessment
Physician-led Versus Peer NP-led POCUS Training
Recruiting
Choice and Autonomy in Learning Mindfulness for Pediatric Residents
Program Engagement, Treatment Adherence and Compliance
Active, not recruiting
Virtual Reality-Based Simulation Versus High-Fidelity Simulation for Emergency Management Training in Medical Interns
Anaphylaxis, Hypoxia
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.
Bayer Study Director study director
Bayer
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Regorafenib (Stivarga, BAY73-4506), iPAD application and Bayer specialist in people with Physician Education, run by Bayer at 17 sites 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 19 inclusion and 13 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: stopped early, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2017.