Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom regorafenib or cetuximab is considered a standard treatment. Patients with metastatic colorectal cancer (mCRC) must have a record of K-ras gene mutational analysis available and no K-ras mutation is present.
Male or female patients ≥ 18 years of age
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
Life expectancy of at least 3 months
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:
* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Mildly elevated total bilirubin (\< 6 mg/dL) is allowed if Gilbert's syndrome is documented.
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
* Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects whose cancer involves their liver).
* Amylase and lipase ≤ 1.5 x ULN
* Serum creatinine ≤ 1.5 times ULN and creatinine clearance (CLcr) ≥ 30 mL/min according to the Cockroft-Gault formula
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
You may not be if
Prior treatment with Regorafenib
Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
Non-healing wound, ulcer, or bone fracture
Systemic anticancer therapy within 28 days
Patients unable to swallow and retain oral medications
