Colorectal neoplasms
Conditions
Interventions
Product Name: Regorafenib
Product Code: Bay 73-4506
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Regorafenib
CAS Number:
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subjects ³ 18 years of age. •Life expectancy of at least 3 months •Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded. •Subjects with metastatic colorectal cancer (Stage IV). •Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan,bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type) •ECOG Performance Status of = 1 (ECOG: Eastern Cooperative Oncology Group) •Adequate bone marrow, liver and renal function •Women of childbearing potential and men must agree to use adequate contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1350
Exclusion criteria
Exclusion criteria: •Prior treatment with regorafenib. •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication treatment •Pregnant or breast-feeding subjects. •Congestive heart failure ³ New York Heart Association (NYHA) class 2. •Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). •Myocardial infarction less than 6 months before start of study drug. •Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). •Uncontrolled hypertension. (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management). •Pleural effusion or ascites that causes respiratory compromise (³ CTCAE Grade 2 dyspnea). (CTCAE: common terminology criteria for adverse events) •Ongoing infection > Grade 2 CTCAE v. 4.0. •Known history of human immunodeficiency virus (HIV) infection. •Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy. •Subjects with seizure disorder requiring medication. •Subjects with evidence or history of any bleeding diathesis, irrespective of severity. •Any hemorrhage or bleeding event ³ CTCAE Grade 3 within 4 weeks prior to the start of study medication. •Non-healing wound, ulcer, or bone fracture. •Renal failure requiring hemo-or peritoneal dialysis. •Dehydration CTCAE v. 4.0 Grade ³ 1. •Interstitial lung disease with ongoing signs and symptoms •Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours). •Any malabsorption condition. •Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity £ Grade 2. •Concomitant participation or participation within the last 30 days in another clinical trial •Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies to assess the safety of regorafenib ; Secondary Objective: to estimate progression free survival (PFS) ; Primary end point(s): The primary endpoint will be safety Safety Analysis Set (SAF) : the population for the safety analyses is the SAF. All subjects who received at least one dose of regorafenib belong to the SAF. •Descriptive summary tables will be presented on all safety parameters. •Subjects will be monitored for adverse events using the NCI-CTCAE version 4.0. (NCI: National Cancer Institute) •Treatment emergent adverse events and safety laboratory parameters will be summarized by NCI-CTCAE version 4.0 grade and by MedDRA terminology. A treatment-emergent AE is defined as any event arising or worsening after the start of study drug administration until 30 days after the last study medication. •AEs that caused subject withdrawal, dose reduction, or interruption will be summarized. •Patients who die during the study will be summarized and listed. •Patients with SAEs will be summarized and listed. •Adverse events leading to discontinuation will be summarized and listed. ;Timepoint(s) of evaluation of this end point: Last patient last visist date (no event-driven primary completion date) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS is the only efficacy variable to be estimated in this study The population for the efficacy analysis is the FAS. All subjects assigned to treatment belong to the FAS. • The Kaplan-Meier curve for PFS and the • Kaplan-Meier estimate of median time to PFS with its confidence interval (CI) • PFS proportions at 1,2,3,4 etc months with CIs ;Timepoint(s) of evaluation of this end point: Last patient last visist date ( no event-driven primary completion date) | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed