Status:
TERMINATED
Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Tumors With Aberrations in ALK or ROS1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 (p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2017
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02186821
Start Date
September 17 2014
End Date
December 13 2017
Last Update
April 8 2021
Active Locations (21)
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1
St Joseph Heritage Healthcare St. Joseph Heritage
Santa Rosa, California, United States, 94503
2
Sarah Cannon Research Institute
Denver, Colorado, United States, 80218
3
Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)
Greenwood Village, Colorado, United States
4
Florida Cancer Specialists Florida Cancer Specialists (31
Fort Myers, Florida, United States, 33901