CLDK378A2X01B Roll over study in patients with ALK postive malignancies
- Conditions
- on Small Cell Lung CancerNSCLC
- Registration Number
- LBCTR2019010182
- Lead Sponsor
- ovartis Pharma Services Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1
•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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: 1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability ;Timepoints: [ Time Frame: Until no patients are left on study up to 5 years ];Measure: up to 5 years
- Secondary Outcome Measures
Name Time Method ame: To evaluate clinical benefit as assessed by;Timepoints: Proportion of patients with clinical benefit;Measure: Confirmation of clinical benfit of study treament