A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors
Inclusion Criteria:
- Solid tumor
- ECOG performance status 0-2
- Life expectancy greater than or equal to 12 weeks
- Must meet certain blood laboratory values
- Must meet criteria for time since the last dose of prior therapy
- Must provide written informed consent to participate in this study
Exclusion Criteria:
- Active and/or symptomatic brain tumors or brain metastases.
- Patients with unresolved nausea, vomiting, or diarrhea
- Any ongoing severe and/or uncontrolled medical condition that could compromise
participation in the study including heart, lung or inflammatory disease
- Any disease that may significantly alter the absorption of the study drug (for
example, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption
syndrome, or removal of small bowel)
- Patients who are currently receiving treatment with steroids at a certain dose or
other immunosuppressive treatment that cannot be stopped prior to starting study drug
- Patients who are currently receiving treatment with certain medications
- Patients who have received radiation therapy or have undergone major surgery within
the last 4 weeks
- Women of child-bearing potential who are pregnant or breast feeding.
- Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active
hepatitis B or C
- Patients unwilling or unable to follow the protocol
Other protocol-defined inclusion/exclusion criteria may apply