Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
Conditions
Tumors With Aberrations in ALK or ROS1
Conditions: Keywords
hematological malignancy, solid tumor malignancy, mutation, translocation, rearrangement, amplification, ALK, ROS1, NSCLC, B-cell lymphoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: Ceritinib (LDK378)
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this signal seeking study is to determine whether treatment with ceritinib demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient has a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or hematological malignancy and is 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 be assessed and reported by a CLIA-certified laboratory. ALK positivity as assessed by IHC or FISH are 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 are anticipated to result in a durable remission.

- Patient has progressive and measurable disease as per RECIST 1.1 or other appropriate hematological guidelines.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

Exclusion Criteria:

- Patient has received prior treatment with ceritinib.

- Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.

- Patient has received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.
Locations
Sarcoma Oncology Center
Santa Monica, California, United States
Status: Recruiting
Contact: - 310-522-9999
Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)
Greenwood Village, Colorado, United States
Status: Recruiting
Contact: - 303-388-4676
Florida Cancer Specialists Research Institute
Fort Myers, Florida, United States
Status: Recruiting
Contact: - 941-792-1881
Northwestern University Northwestern (6)
Chicago, Illinois, United States
Status: Recruiting
Contact: - 312-695-0184
Horizon Oncology Center
Lafayette, Indiana, United States
Status: Recruiting
Contact: - 765-446-5111
Maryland Oncology Hematology, P.A. Dept. of Assoc. Onc/Hem
Rockville, Maryland, United States
Status: Recruiting
Holy Cross Hospital Holy Cross (2)
Silver Spring, Maryland, United States
Status: Recruiting
Contact: - 301-754-8556
Washington University School of Medicine Washington University (16)
St. Louis, Missouri, United States
Status: Recruiting
Contact: - 314-362-6963
Southeast Nebraska Oncology
Lincoln, Nebraska, United States
Status: Not yet recruiting
Contact: - 402-327-7363
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
Las Vegas, Nevada, United States
Status: Recruiting
Contact: - 702-952-3426
New Mexico Oncology Hematology
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: - 505-842-8171
University of New Mexico Hospital Cancer Care Alliance
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: - 505-272-6057
Duke University Medical Center Seeley G. Mudd Bldg.
Durham, North Carolina, United States
Status: Recruiting
Contact: - 919-681-6006
Wake Forest University Health Sciences Health Sciences
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: - 336-716-7972
Sanford Hematology Oncology
Fargo, North Dakota, United States
Status: Not yet recruiting
Contact: - 701-234-2371
Salem Health
Salem, Oregon, United States
Status: Recruiting
Contact: - 503-561-6455
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: - 215-537-7400
Rhode Island Hospital Rhode Island Hosp. (2)
Providence, Rhode Island, United States
Status: Recruiting
Contact: - 401-444-3059
Sanford Research Sanford Clinical Research
Sioux Falls, South Dakota, United States
Status: Not yet recruiting
Contact: - 605-328-8000
The West Clinic SC-4
Memphis, Tennessee, United States
Status: Not yet recruiting
Contact: - 901-683-0055
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
Houston, Texas, United States
Status: Recruiting
Contact: - 216-255-2748
Oncology Consultants Oncology Group
Houston, Texas, United States
Status: Recruiting
Contact: - 832-824-5383
Utah Cancer Specialists Utah Cancer Specialists
Salt Lake City, Utah, United States
Status: Recruiting
Contact: - 801-281-6863
Vista Oncology Inc. PS
Olympia, Washington, United States
Status: Not yet recruiting
Contact: - 360-352-2900
Seattle Cancer Care Alliance Skagit Valley Hospital
Seattle, Washington, United States
Status: Recruiting
Contact: - 360-814-2146
Swedish Cancer Institute Swedish Cancer Institute
Seattle, Washington, United States
Status: Recruiting
Start Date
September 2014
Completion Date
September 2018
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page