Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy (NCT02307500) | Clinical Trial Compass
CompletedPhase 2
Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy
Italy82 participantsStarted 2014-12
Plain-language summary
This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib in patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma, sarcoma, thymoma (type B2 - B3) and thymic carcinoma, who have progressed after standard therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent
✓. Patients older then 18 years.
✓. Locally advanced, recurrent or metastatic histologically confirmed malignancy refractory to available standard treatment, included Pancreatic cancer, Ovarian cancer, Melanoma, Sarcoma
✓. At least one measurable lesion according to Response Evaluation Criteria In solid tumor
✓. Eastern Cooperative Oncology Group Performance Status: 0-1
✓. Life expectancy of at least 12 weeks
✓. Adequate bone marrow, liver and renal function as assessed by the following laboratory : Hemoglobin \> 9.0 g/dl Absolute neutrophil count \> 1,500/mm3 Platelet count \> 100,000/μl White blood cells \>3.0 x 109/L Total bilirubin \<1.5 times the upper limit of normal Alanine amino transferase and aspartate amino transferase \<2.5 x upper limit of normal (\<5 x upper limit of normal for patients with liver involvement) Serum creatinine \<1.5 x upper limit of normal Alkaline phosphatase \<2.5 x Upper Limit of Normal Prothrombin time / Partial prothrombin time \<1.5 x Upper Limit of Normal Lipase ≤ 1.5 x the Upper Limit of Normal
✓. Able to swallow and retain oral medication.
Exclusion criteria
✕. Prior treatment with regorafenib.
✕. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
✕
What they're measuring
1
activity of regorafenib screening, in terms of 2-months progression free survival rate