REGORAFENIB TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Unmanageable drug-drug interaction
- Clinically significant cardiovascular disease (uncontrolled hypertension, unstable or new-onset angina, myocardial infarction within prior 6 months, history of congestive heart failure New York Heart Association Class 3 or 4)
- Pre-existing bleeding diathesis or coagulopathy
- Major surgical procedure within prior 28 days, non-healing wound, ulcer or bone fracture
- Hepatic impairment: Total bilirubin > 1.5 x Upper Limit of Normal (> 6 mg/dL if documented Gilbert’s syndrome); ALT and AST > 2 x ULN (> 5 x ULN if due to liver involvement); Alk phos > 2.5 x ULN (> 5 x ULN if due to liver involvement)
- Amylase and lipase > 1.5 x ULN
- GFR < 30 mL/min/1.73 m2
- Adequate hematologic parameters: platelet count < 100,000/mm3, hemoglobin < 9 mg/dL and ANC < 1500/mm3
- Known pregnancy
- Lactation
General Inclusion Criteria
- Care provided by a VA/VA Community care oncology or hematology provider
- Goals of care and role of Palliative Care consult discussed and documented
- Eastern Cooperative Oncology Group Performance Status 0 or 1
Indication-Specific Inclusion Criteria (One must be met)
- Metastatic colorectal cancer with prior treatment (or not a candidate) for fluoropyrimidine-, oxaliplatin-, irinotecan-based regimens, an anti-VEGF agent and if KRAS wild type, an anti-EGFR agent
- Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) with prior therapy with imatinib and sunitinib (unless contraindicated)
- Hepatocellular carcinoma (HCC) Child-Pugh A, previously treated with sorafenib
Pregnancy & Reproductive Requirements
- For females who can become pregnant: Pregnancy must be excluded prior to receiving regorafenib
- For females who can become pregnant and males with partners who can become pregnant: Counseling provided on potential risks vs. benefits of treatment and the use of effective contraception during pregnancy and for 2 months after stopping treatment