- Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a
candidate for definitive multimodality therapy) or stage IV NSCLC demonstrated
ALK-positive or an advanced tumor, other than NSCLC, that carries an ALK genetic
alteration (mutation, translocation or amplification) and/or ALK overexpression that
has progressed despite standard therapy, or for which no effective standard therapy
- The test to confirm ALK-positivity may be performed in archival tumor (obtained at or
since the time of diagnosis), or in a newly obtained tumor sample taken prior to the
first day of study drug. Results confirming ALK-positive status must be available
before initiating treatment with ceritinib.
- Patients who have received prior chemotherapy, other ALK inhibitors, biologic
therapy, or other investigational agents, must have recovered from all toxicities
related to prior anticancer therapies to grade 1 (CTCAE v 4.03) prior to starting
study drug. Patients with grade 2 peripheral neuropathy or any grade of alopecia,
nail changes or skin changes are allowed to enter the study.
- Patients who have been treated with chemotherapy, with biological therapy or other
investigational agent must have discontinued the treatment at least 2 weeks (14 days)
prior to starting the study drug on Study Day -
- Patient has the ability to understand and provide signed informed consent.
- Patients with known hypersensitivity to any of the excipients of ceritinib
(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and
magnesium stearate), midazolam and warfarin as described in the local product
- History of carcinomatous meningitis.
- Presence or history of a malignant disease other than an ALK-positive advanced tumor
that has been diagnosed and/or required therapy within the past 3 years. Exceptions
to this exclusion include the following: completely resected basal cell and squamous
cell skin cancers, and completely resected carcinoma in situ of any type.
- Clinically significant, uncontrolled heart disease and/or recent cardiac event
(within 6 months
- Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) 160 mmHg
and/or Diastolic Blood Pressure (DBP) 100 mmHg, with or without anti-hypertensive
- Patient has history of interstitial lung disease or interstitial pneumonitis,
including clinically significant radiation pneumonitis (i.e., affecting activities of
daily living or requiring therapeutic intervention).
- Other Protocol defined Inclusion/Exclusion may apply.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Phamacokinetics (PK) parameters of probe drugs and their metabolites in the absence or presence of ceritinib dosing, including but not limited to: AUCinf
PK parameters of probe drugs and their metabolites in the absence or presence of ceritinib dosing, including but not lastlimited to: AUC
PK parameters of probe drugs and their metabolites in the absence or presence of ceritinib dosing, including but not lastlimited to:Cmax
PK parameters of probe drugs and their metabolites in the absence or presence of ceritinib dosing, including but not lastlimited to:Tmax