Inclusion Criteria:
- 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
exists.
- 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.
Exclusion Criteria:
- 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
information.
- 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
medication.
- 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