Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)

Stopped early · Phase 2

Conditions studied: Tumors With Aberrations in ALK or ROS1

In brief

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.

Key facts

Study ID

NCT02186821

Run by

Novartis Pharmaceuticals

People needed

47

Starts

2014-09-17

Expected to finish

2017-12-13

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient had a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or hematological malignancy and was in need of treatment because of radiologic progression or relapse.
• Patient must have been pre-identified as having a tumor with an ALK or ROS1 positive mutation, translocation, rearrangement or amplification. The qualifying alteration must have been assessed and reported by a CLIA-certified laboratory. ALK positivity as assessed by IHC or FISH were allowed.
• Patient must have received at least one prior treatment for recurrent, metastatic and/or locally advanced disease and for whom no standard therapy options were anticipated to result in a durable remission.
• Patient had progressive and measurable disease as per RECIST 1.1 or other appropriate hematological guidelines.
• Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

You may not qualify if…

• Patient had received prior treatment with ceritinib.
• Patients with symptomatic CNS metastases who were neurologically unstable or required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
• Patient had received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.

Where it is running

• 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

Full record on ClinicalTrials.gov

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