Safety and Efficacy of LCL161 in Patients With Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: LCL161

• Registration Number: NCT01098838
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-01
• Study First Posted: 2010-04-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-02
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weekly dosing of LCL161	LCL161	by mouth (oral)
Comparison of LCL161	LCL161	tablet versus liquid
Twice daily dosing of LCL161	LCL161	by mouth for 4 days followed by a 3-day rest period every week

Primary Outcome Measures

Name	Time	Method
Occurrence of dose-limiting toxicities	Cycle 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2); 🇺🇸 Chapel Hill, North Carolina, United States

Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2); 🇺🇸 Nashville, Tennessee, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States