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NCT02034981 : Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1
PhasePhase 2
AgesMin: 1 Year Max: N/A

- Male and female ? 1 year of age

- unresectable locally advanced or metastatic malignant tumor of any histological type
(but NSCLC with an ALK translocation) and not amenable to any other validated
therapeutic option. ( for pediatrics a relapse after a first well-conducted standard
treatment or a situation without any standard treatment and a survival <10%).

- one proven specific alterations among ALK, MET, RON and ROS1 genes determined on the
primary and/or the metastatic lesion

- Measurable disease according to RECIST 1.1

- For patients with primary cerebral tumors (adults or children), measurable disease
defined by bi-dimensional measurements : two perpendicular diameters of at least 10
mm on CT or MRI scan, outside of a previously radiated field within the last 3
months, to observe pseudoprogression

- hematologic function (ANC ? 1.0x109/L, platelets ? 75x109/L, platelets ? 50x109/L for
ALCL with bone marrow involved ; platelets ? 100x109/L for primary or secondary
cerebral tumors; Hb ? 8g/L), renal function (creat cl ? 50 mL/min Cockcroft and
Gault) and hepatic function (serum bilirubin ? 1.5x ULN unless due to Gilbert's
syndrome ; ASAT and ALAT ? 5x ULN if liver metastasis or ? 3x ULN if liver metastasis
with advanced fibrosis (FibroTest>0.48) or ? 3x ULN without liver metastasis)

- normal values for calcium, magnesium and potassium levels

- able to swallow and retain oral medication

- ECOG Performance Status of 0 to 2, or Karnofsky scale > 50 % or Lansky Play scale (<
12 years) > 50%, (for CNS tumors, the neurological deficiency due to the disease

- Life expectancy ? 3 months

Exclusion :

- NSCLC patients ALK translocations

- Patient eligible for a clinical trial with an anticancer drug (including crizotinib)
targeting the same molecular alteration open to accrual in France.

- alteration limited to an overexpression of ALK, MET, RON, ROS1 or any other
crizotinib-target. Only patients with ALCL are eligible if ALK is positive by

- Patients with primary or secondary central nervous system disease

- Previous treatment with crizotinib

- Major surgery or tumor embolization within 4 weeks and minor surgery within 2 weeks
prior to the initiation of the study drug. Brain surgery is excluded within 4 weeks
prior to starting crizotinib for primary or secondary cerebral tumors

- Patients with other concurrent severe and/or uncontrolled medical disease which could
compromise participation in the study, such as, but not limited to :

- Within the 3 months prior to starting study treatment: myocardial infarction,
severe/unstable angina, coronary/peripheral artery bypass graft, or
cerebrovascular accident including transient ischemic attack

- Ongoing congestive heart failure

- Congenital long QT syndrome

- Heart rate ? 45 beats/minute

- Ongoing cardiac dysrhythmias of NCI CTCAE Grade ?2, uncontrolled atrial
fibrillation of any grade, or with QTcF interval >470 msec

- For patients with a cerebral disease (primary or secondary) : uncontrolled
hypertension [defined as SBP of ? 140 mmHg or DBP of ? 90mmHg]

- extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial
fibrosis or interstitial lung disease, including pneumonitis, hypersensitivity
pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative
bronchiolitis, and pulmonary fibrosis, but not prior radiation pneumonitis

- Spinal cord compression unless treated with the patient attaining good pain
control and stable or recovered neurologic function

- Carcinomatous meningitis or leptomeningeal disease

- HIV-positive, active hepatitis A, B or C, or latent hepatitis B or C, or any
other uncontrolled infection

- Other severe acute or chronic medical or psychiatric conditions, or end stage
renal disease on hemodialysis or laboratory abnormalities

- For patients with a cerebral disease, detection on the MRI or the CTscan of a
real arteriovenous malformation, or an untreated intracranial aneurysm, or a
cavernous angioma, or an amyloid angiopathy, or any new or significant (? grade
2) intratumoral bleeding other than microbleeds on T2* weighted MRI in the
previous 14 days before treatment initiation, or a recent and untreated subdural

- Patients using non-substitutable drugs that are potent CYP3A4 inhibitors, or potent
CYP3A4 inducers

- Patients using non-substitutable drugs that are CYP3A4 substrates with narrow
therapeutic indices

- Patients with cerebral disease using anti-platelet drugs or anticoagulant agents are
not eligible if those treatments can not be stopped 7 days before day1.

- Patients with altered mental status or with psychological, familial, sociological or
geographical condition potentially hampering compliance

- Individual deprived of liberty or placed under the authority of a tutor.
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