Advanced solid tumors and hematological malignancies with ALK genetic alteration and/or overexpression
Conditions
Interventions
Trade Name: Zykadia
Product Name: ceritinib
Product Code: LDK378
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ceritinib
Current Sponsor code: LDK378
Other descriptive name: CERITINIB
Concen
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent for the main study obtained prior to any screening procedure. - Patient must provide an archival or fresh tumor tissue before the first dose of the study drug for ALK testing at a Novartis designated central laboratory by a comparative technology: the confirmation of ALK positivity is not required for enrollment if other inclusion and exclusion criteria are fulfilled - Patient is 18 years or older at the time of informed consent. - Patient has WHO performance status ? 2. - Patient has at least one measurable lesion as defined by appropriate guidelines. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation Other protocol related inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
Exclusion criteria: 1. Patient with ALK+ lung cancer. 2. Patient with known hypersensitivity to any of the excipients of LDK378. 3. Patient 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. 4. History of carcinomatous meningitis. 5. Patient with diarrhea CTCAE ? grade 2; or patients with neuropathy CTCAE ? grade 2 Other protocol related exclusion criteria may apply.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ORR, defined as the proportion of patients with a best overall response defined as CR or PR; (CR+PR) 2. The following endpoints will be evaluated by investigator assessment : ? DOR, 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 - TTR, defined as the time from date of the first dose to date of first documented response (CR or PR) ? PFS, defined as time from date of the first dose to date of first documented disease progression or date of death due to any cause 3. ECG, Performance status, Vital signs, Physical examination; AEs, and laboratory (hematology, biochemistry, urinalysis, coagulation, pregnancy test and hormones (males only);Timepoint(s) of evaluation of this end point: at week 16 | — |
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): DCR, defined as the proportion of patients with best overall response of CR, PR, or SD ? 16 weeks;Timepoint(s) of evaluation of this end point: at week 16;Main Objective: To assess the antitumor activity of ceritinib as measured by DCR determined by investigators;Secondary Objective: - To assess the antitumor activity of ceritinib as measured by ORR, DOR, TTR as determined by investigators - To assess the antitumor activity of ceritinib as measured by PFS determined by investigators - To assess the safety and tolerability of ceritinib. | — |
Countries
Argentina, Belgium, Czech Republic, Denmark, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Spain, Thailand
Contacts
Public ContactDepartamento Médico Oncología (GMO)
Novartis Farmacéutica, S.A.
Outcome results
None listed