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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly dosing of LCL161 | Experimental | by mouth (oral) |
|
| Comparison of LCL161 | Experimental | tablet versus liquid |
|
| Twice daily dosing of LCL161 | Experimental | by mouth for 4 days followed by a 3-day rest period every week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCL161 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of dose-limiting toxicities | Cycle 1 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2) | Chapel Hill | North Carolina | 27599-7295 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25113756 | Derived | Infante JR, Dees EC, Olszanski AJ, Dhuria SV, Sen S, Cameron S, Cohen RB. Phase I dose-escalation study of LCL161, an oral inhibitor of apoptosis proteins inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2014 Oct 1;32(28):3103-10. doi: 10.1200/JCO.2013.52.3993. Epub 2014 Aug 11. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C574246 | LCL161 |
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| 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 |
| Fox Chase Cancer Center |
| Philadelphia |
| Pennsylvania |
| 19111-2497 |
| United States |
| Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2) | Nashville | Tennessee | 37203 | United States |