Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Wake Forest University Health Sciences
With
OUTLINE: This is a multi-center study. INVESTIGATIONAL TREATMENT: Regorafenib will be administered 160 mg orally once daily for the first 21 days of each 28-day cycle. Subjects that randomize to receive ginseng will take 1,000 mg orally twice daily every day for 4 weeks (2 cycles). Subjects that randomize to NOT receive ginseng will not be given ginseng. Subjects will be instructed to take regorafenib with a low-fat meal. Subjects will undergo fatigue assessments, using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument and Patient-Reported Outcomes Measurement Information System (PROMIS). Subjects will have a pill count cycle 2 day 1 (C2D1) and at the end of treatment visit. Subjects will have the re-staging scan (CT of chest/abdomen/pelvis) at the end of Cycle 2/ week 8 (±5). Adequate bone marrow, liver and renal function assessed by the following laboratory values obtained within 7 days prior to registration for protocol therapy: Hematopoietic: * Absolute neutrophil count (ANC) count \> 1,500/mm\^3 * Hemoglobin (Hgb) \> 9g/dL * Platelet count \> 100,000/mm\^3 Renal: * Serum creatinine ≤ 1.5 × the upper limit of normal (ULN) Hepatic: * Total bilirubin ≤ 1.5 × the upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 × ULN for subjects with liver involvement of their cancer) * Alkaline phosphatase (ALP) limit ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver involvement of their cancer) Coagulation: * International normalized ratio (INR)/Partial thromboplastin time (PTT) ≤ 1.5 × ULN. NOTE: Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable, based on a measurement that is pre-dose as defined by the local standard of care. Warfarin does should not exceed 1 mg.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
