This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.
Novartis Investigative Site
Brno, Czech Republic, Czechia
Novartis Investigative Site
Copenhagen, Denmark
Novartis Investigative Site
Lyon, France
Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment
The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).
Time frame: Baseline up to approximately 16 weeks
Overall Response Rate (ORR) Per Investigator Assessment
ORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.
Time frame: Baseline, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeks
Duration of Response (DOR) Per Investigator Assessment
DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause
Time frame: Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks
Time to Response (TTR) Per Investigator Assessment
TTR is defined as the time from date of the first dose to date of first documented response (CR or PR)
Time frame: Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks
Progression Free Survival (PFS) Per Investigator Assessments
PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause
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Novartis Investigative Site
Saint-Herblain Cédex, France
Novartis Investigative Site
Strasbourg, France
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
...and 4 more locations
Time frame: Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeks
Percent of Participant Deaths During Treatment and Follow-up
Deaths due to any cause during treatment and 30 day follow-up
Time frame: Baseline up to approximately 84 weeks