Clinical Trial Details
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NCT02605746 : Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis
PhaseEarly Phase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- One prior resection of GBM or MRI evidence of solid tumor CNS metastasis

- All GBM and NSLC metastases must be ALK+

- Eastern Cooperative Oncology Group performance status =2

- Archival tumor tissue block available for research use

- Ability to understand written informed consent

- Recovery from toxicities related to prior anticancer therapies to = grade 2 (CTCAE v
4.03). Exception: patients with any grade alopecia

- The following lab criteria are met:

- Absolute neutrophil count = 1.5 x 10(9th power)/L

- Hemoglobin = 8 g/dL

- Platelets = 75 x 10(9th power)/L

- Serum total bilirubin = 1.5 x upper limit of normal(ULN), except for patients
with Gilbert's syndrome who may be included if total bilirubin = 3.0 x ULN and
direct bilirubin = 1.5 x ULN

- Aspartate transaminase (AST) < 3.0 x ULN, except for patients with liver
metastasis, who are only included if AST < 5 x ULN; alanine transaminase (ALT) <
3.0 x ULN, except for patients with liver metastasis, who are only included if
ALT < 5 x ULN

- Creatinine clearance = 30 mL/min

- Patient has following lab values or has lab values corrected with supplements to be
within normal limits at screening:

- Potassium = LLN

- Magnesium = LLN

- Phosphorus = LLN

- Total calcium (corrected for serum albumin) = LLN

Exclusion Criteria:

- Co-morbid condition(s) that prevent safe surgical treatment

- Active infection or fever > 38.5°C

- Patients with known hypersensitivity to any excipients of ceritinib

- Prior therapy with ceritinib

- Patients with known history of extensive disseminated bilateral interstitial fibrosis
or interstitial lung disease, including a history of pneumonitis, hypersensitivity
pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically
significant radiation pneumonitis (affecting activities of daily living or requiring
therapeutic intervention)

- Clinically significant uncontrolled heart disease and/or recent cardiac event (within
6 months), such as:

- history of documented congestive heart failure (New York Heart Association
functional classification III-IV);

- uncontrolled hypertension defined by a Systolic Blood Pressure = 160 mm Hg and/or
Diastolic Blood Pressure = 100 mm Hg, with or without antihypertensive medication

- initiation or adjustment of antihypertensive medication(s) is allowed prior to

- ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled
with medication;

- other cardiac arrhythmia not controlled with medication;

- corrected QTc > 450 msec using Fridericia correction on the screening ECG

- Impaired GI function or GI disease that may alter absorption of ceritinib or inability
to swallow up to five ceritinib capsules daily

- Ongoing GI adverse events > grade 2 (e.g. nausea, vomiting, or diarrhea) at the start
of the study

- Receiving medications that meet 1 of the following criteria and cannot be discontinued
at least 1 week prior to start of treatment with ceritinib and for the duration of

- Medication with a known risk of prolonging the QT interval or inducing Torsades
de Pointes

- Strong inhibitors or strong inducers of CYP3A4/5

- Medications with a low therapeutic index that are primarily metabolized by
CYP3A4/5, CYP2C8 and/or CYP2C9

- Therapeutic doses of warfarin sodium (Coumadin) or any other coumadin-derived
anti-coagulant. Anticoagulants not derived from warfarin are allowed

- Pregnant or nursing (lactating) women.

- Women of child-bearing potential, unless they are using highly effective methods of
contraception during dosing and for 3 months after the last dose of study treatment.
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