Title Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma
Principal Investigator Nikhil Khushalani, MD
Study Number 197811
Summary This phase II study will consist of single agent axitinib in the treatment of patients with advanced melanoma. Response will be assessed after every 2 cycles and treatment will continue until disease progression or drug related harm to the patient.
- Histologically or cytologically proven melanoma that is advanced (metastatic) or unresectable
- Have the ability to swallow and retain oral medication
- No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be < 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- Major surgery less than 4 weeks or radiation therapy less than 2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
- Significant history of bleeding events within 6 months prior to registration.
- Gastrointestinal abnormalities including: inability to take oral medication, requiring sustenance intravenously, prior surgical procedures affecting absorption including total gastric resection; segmental small bowel or colon resection is permitted; treatment for active peptic ulcer disease in the past 6 months; active gastrointestinal bleeding, unrelated to cancer, in the past 6 months without evidence of resolution documented by endoscopy or colonoscopy; malabsorption syndromes; and history of GI perforation within prior 12 months.