ALK Positive Malignancies
Conditions
Keywords
ALK, Malignancies
Brief summary
The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.
Interventions
DRUGceritinib
hard gelatin capsule or hard tablet for oral use up to 750 mg
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment. * Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. * Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. * Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.
Exclusion criteria
* Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason. * Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months afer stopping ceritinib treatment. * Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until no patients are left on study up to 5 years | To collect safety data: adverse events and serious adverse events |
Countries
Australia, Belgium, Brazil, Bulgaria, China, Colombia, Czechia, France, Germany, Hong Kong, Italy, Japan, Lebanon, Malaysia, Poland, Russia, Singapore, South Korea, Spain, Taiwan, United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed