malignancies characterized by genetic abnormalities in anaplastic lymphoma kinase (ALK)
Conditions
Interventions
Product Code: LDK378
Pharmaceutical Form: Capsule
Other descriptive name: LDK378
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists - Age = 12 months and = 17years - The tumor must carry a genetic alteration of ALK - Patients must have evaluable or measurable disease Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy (such as radiotherapy, surgery or intrathecal chemotherapy) to control their CNS disease - Clinically significant, uncontrolled heart disease - Inadequate end organ function as defined by specified laboratory values - Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study - Use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study. Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimate the MTD and/or RDE of LDK378 as a single agent when administered orally to pediatric patients with ALK-activated tumors ; Secondary Objective: 1 -Characterize the safety and tolerability of LDK378 in the pediatric patients 2- Characterize single and multiple-dose PK of LDK378 in pediatric patients 3- Assess the anti-tumor activity of LDK378 ;Primary end point(s): Incidence rate of Dose Limiting Toxicities (DLT);Timepoint(s) of evaluation of this end point: up to day 21 after the patient's first dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Number of patients with Adverse events and serious adverse events; Changes in laboratory values ; Assessments of physical examinations; Assessments of vital signs and electrocardiograms; Plasma concentration time profiles 2- PK parameters, including AUClast, AUCtau, Cmin, Cmax, Tmax, Racc T1/2 and acc 3- Overall response rate (ORR) and duration of response (DOR), progression-free survival (PFS) as per RECIST 1.1; Changes in disease burden in patients with lymphoma. ; Timepoint(s) of evaluation of this end point: 1- 30 months 2- 30 months 3- 30 months | — |
Countries
Australia, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom
Contacts
Public ContactInformation&communication médicales
Novartis Pharma S.A.S.
Outcome results
None listed