A Phase I, Multicenter, Open-label Dose Escalation Study of LDK378, Administered Orally in Japanese Patients With Tumors Characterized by Genetic Alterations in ALK
Inclusion Criteria:
- Patients with a locally advanced or metastatic malignancy that has progressed despite
standard therapy, or for which no effective standard therapy exists
- Only patients with tumors characterized by genetic alterations in ALK. For non-small
cell lung cancer (NSCLC), an ALK translocation must be detected by Fluorescent in
situ hybridization (FISH) in ≥15% of tumor cells. Local site documented results on
ALK alteration are acceptable for enrollment of the patients. Central confirmation of
local results is not required.
--Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
- Adequate organ function
Exclusion Criteria:
- Patients with symptomatic Central Nerve System (CNS) metastases who are
neurologically unstable or require increasing doses of steroids to control their CNS
disease
- Patients with unresolved nausea, vomiting or diarrhea > Common Terminology Criteria
for Adverse Events (CTCAE) grade 1
- Other concurrent severe and/or uncontrolled medical conditions
- Patients who have been treated with chemotherapy or biologic therapy or other
investigational agent < 2 weeks prior to starting study drug for compounds with a
half-life ≤ 3 days, and < 4 weeks prior to starting study drug for compounds with a
prolonged half-life (< 6 weeks for patients that received nitrosoureas or
mitomycin-C)
- Unresolved toxicity greater than CTCAE grade 1 or unstable toxicity from previous
anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity,
lymphopenia), or incomplete recovery from previous surgery, unless agreed by Novartis
and the Principal Investigator and documented
- Patients who have received radiotherapy to a large volume (including whole brain
radiotherapy) < 2 weeks prior to starting study drug, and patients who have received
radiotherapy to a small volume (including stereotactic radiotherapy to the CNS) < 3
days prior to starting study drug.
Other protocol-defined inclusion/exclusion criteria may apply.