Advanced Solid Tumors
Conditions
Keywords
Cancer, adults, solid tumor, apoptosis, programmed cell death, LCL161
Brief summary
The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.
Interventions
DRUGLCL161
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dose-limiting toxicities | Cycle 1 |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and type of adverse events | throughout the study |
| Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability) | 3 months |
| Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters) | 4 weeks |
| Pharmacodynamic measurements to determine how LCL161 interacts with proteins related to cancer such as cIAP, cytokines, and cell death markers; hair, skin and tumor samples will be evaluated for target inhibition | Intermittent throughout treatment period |
| Solid tumor response criteria will be used to identify any anti-tumor activity | After a minimum of 2 cycles |
Countries
United States
Outcome results
None listed