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

NCT02287025 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 17347
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death

  Up to 1 year

Secondary Outcomes (5)

• Duration of Treatment

  Up to 1 year

• Dose Intensity as Percentage of Planned Dose

  Up to 1 year

• Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension

  Up to 1 year

• Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire

  Up to 1 year

• Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire

  Up to 1 year

Study Arms (2)

SMART

EXPERIMENTAL

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

Drug: Regorafenib (Stivarga, BAY73-4506); Other: iPAD application

Standard of Care

ACTIVE COMPARATOR

Investigators were supported with standard prescribing information.

Drug: Regorafenib (Stivarga, BAY73-4506); Other: Bayer specialist

Interventions

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

SMART; Standard of Care

iPAD application OTHER

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

SMART

Bayer specialist OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Bayer: lead

Study Sites (17)

Unknown Facility

Anniston, Alabama, 36207, United States

Location

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Orange, California, 92668, United States

Location

Unknown Facility

Lake City, Florida, 32024, United States

Location

Unknown Facility

Skokie, Illinois, 60076, United States

Location

Unknown Facility

Skokie, Illinois, 60077, United States

Location

Unknown Facility

Lafayette, Indiana, 47905, United States

Location

Unknown Facility

Columbia, Maryland, 21044, United States

Location

Unknown Facility

Fayetteville, North Carolina, 28304, United States

Location

Unknown Facility

Canton, Ohio, 44718, United States

Location

Unknown Facility

Tulsa, Oklahoma, 74146, United States

Location

Unknown Facility

Gettysburg, Pennsylvania, 17325, United States

Location

Unknown Facility

Kingsport, Tennessee, 37660, United States

Location

Unknown Facility

Houston, Texas, 77024, United States

Location

Unknown Facility

Tyler, Texas, 75701, United States

Location

Unknown Facility

Bristol, Virginia, 24201, United States

Location

Unknown Facility

Portsmouth, Virginia, 23704, United States

Location

MeSH Terms

Interventions

regorafenib

Limitations and Caveats

The study was terminated prematurely due to slow recruitment (23/300 subjects enrolled). No statistical analyses of efficacy parameters were performed.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: November 10, 2014
• Study Start: November 11, 2014
• Primary Completion: February 26, 2016
• Study Completion: April 8, 2016
• Last Updated: October 19, 2017
• Results First Posted: October 19, 2017

Record last verified: 2017-07

Locations

US (17)