Spots Global Cancer Trial Database for Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
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Trial Identification
Brief Title: Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
Official Title: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module - 7 Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1
Study ID: NCT02186821
Conditions
Interventions
Study Description
Brief Summary: The purpose of this signal seeking study was to determine whether treatment with ceritinib demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Detailed Description: This was an open label study to determine the efficacy and safety of treatment with ceritinib in patients with a diagnosis of solid tumors or hematological malignancies that had been pre-identified (prior to study consent) to have ALK or ROS1 positive mutations, translocations, rearrangements or amplifications and whose disease had progressed on or after standard treatment. The study consisted of a treatment phase where all patients received ceritinib capsules for a total dose of 750 mg daily for up to 8 cycles of 28 days. Disease assessments for clinical benefit were performed every 8 weeks until disease progression or end of treatment. Following discontinuation of treatment for any reason, patients were followed for safety for 30 days. Survival information was collected every 3 months until 2 years after the last patient had enrolled into the study. Study was amended to allow for discontinuation of survival period if primary endpoint was not met. Study was terminated due to low enrollment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St Joseph Heritage Healthcare St. Joseph Heritage, Santa Rosa, California, United States
Sarah Cannon Research Institute, Denver, Colorado, United States
Rocky Mountain Cancer Centers Dept of Rocky Mountain (2), Greenwood Village, Colorado, United States
Florida Cancer Specialists Florida Cancer Specialists (31, Fort Myers, Florida, United States
Northwestern University Northwestern (6), Chicago, Illinois, United States
Physicians Clinic of Iowa, Cedar Rapids, Iowa, United States
Holy Cross Hospital Holy Cross (2), Silver Spring, Maryland, United States
Southeast Nebraska Oncology, Lincoln, Nebraska, United States
Comprehensive Cancer Centers of Nevada CCC of Nevada (1), Las Vegas, Nevada, United States
Duke University Medical Center Seeley G. Mudd Bldg., Durham, North Carolina, United States
Wake Forest Baptist Health Health Sciences, Winston-Salem, North Carolina, United States
Sanford Hematology Oncology, Fargo, North Dakota, United States
Columbus Hematology and Oncology PA Columbus Hem and Onc (2), Columbus, Ohio, United States
Andrew and Patel Associates, Camp Hill, Pennsylvania, United States
Rhode Island Hospital Rhode Island Hosp. (2), Providence, Rhode Island, United States
Sanford University of South Dakota Medical Center Sanford Clinical Research, Sioux Falls, South Dakota, United States
Oncology Consultants Oncology Group, Houston, Texas, United States
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3), Houston, Texas, United States
Utah Cancer Specialists Utah Cancer Specialists, Salt Lake City, Utah, United States
Swedish Cancer Institute Swedish Cancer Institute, Seattle, Washington, United States
Aurora Research Institute, Milwaukee, Wisconsin, United States
Contact Details
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