Safety and Tolerability of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors

A Phase I Study of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors

This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.

Inclusion criteria:

1. Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
2. ECOG performance status 0-1.
3. Patients must have recovered from all toxicities related to their previous treatment.

Exclusion criteria:

1. Unresolved nausea, vomiting, diarrhea or peripheral neuropathy CTCAE grade >1.
2. History of or current interstitial lung disease or autoimmune disease.
3. History of or current impaired cardiac function or clinically significant cardiac diseases.
4. Women of child-bearing potential, unless they are using highly effective methods of contraception.

Other protocol-defined inclusion/exclusion criteria may apply.