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

NCT ID: NCT02186821

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-17
• Study Completion Date: 2017-12-13

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.

Conditions

Tumors With Aberrations in ALK or ROS1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ceritinib 750 mg

Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.

Group Type: EXPERIMENTAL

Ceritinib

Intervention Type: DRUG

Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally,once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days. There were no breaks between dosing cycles.

Interventions

Ceritinib

Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally,once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days. There were no breaks between dosing cycles.

Intervention Type: DRUG

Other Intervention Names

LDK378

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

CLDK378AUS23

Identifier Type: -

Identifier Source: org_study_id