A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?

NCT ID: NCT02287025

Last Updated: 2017-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-11
• Study Completion Date: 2016-04-08

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SMART

Investigators were supported with enhanced drug-specific information via an iPad application (SMART).

Group Type: EXPERIMENTAL

Regorafenib (Stivarga, BAY73-4506)

Intervention Type: DRUG

Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off

iPAD application

Intervention Type: OTHER

Investigators were supported with enhanced drug-specific information via an iPad application (SMART).

Standard of Care

Investigators were supported with standard prescribing information.

Group Type: ACTIVE_COMPARATOR

Regorafenib (Stivarga, BAY73-4506)

Intervention Type: DRUG

Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off

Bayer specialist

Intervention Type: OTHER

The treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise.

Interventions

Regorafenib (Stivarga, BAY73-4506)

Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off

Intervention Type: DRUG

iPAD application

Investigators were supported with enhanced drug-specific information via an iPad application (SMART).

Intervention Type: OTHER

Bayer specialist

The treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:

1. Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)

2. Alanine aminotransferase (ALT) and aspartate aminotransferease (AST)

≤ 3.0 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)

3. Alkaline phosphastase limit ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)

4. Lipase ≤ 1.5 x the ULN

5. Amylase ≤ 1.5 x the ULN

6. Serum creatinine ≤ 1.5 x the ULN

7. 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.

• 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.

Exclusion Criteria

• 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:

1. Congestive heart failure - New York Heart Association (NYHA) > Class II

2. Active coronary artery disease

3. Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin

4. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Anniston, Alabama, United States

Anaheim, California, United States

Orange, California, United States

Lake City, Florida, United States

Skokie, Illinois, United States

Skokie, Illinois, United States

Lafayette, Indiana, United States

Columbia, Maryland, United States

Fayetteville, North Carolina, United States

Canton, Ohio, United States

Tulsa, Oklahoma, United States

Gettysburg, Pennsylvania, United States

Kingsport, Tennessee, United States

Houston, Texas, United States

Tyler, Texas, United States

Bristol, Virginia, United States

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

17347

Identifier Type: -

Identifier Source: org_study_id