Safety and Efficacy of LCL161 in Patients With Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098838
• Other study ID #: CLCL161A2101
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2010
• Last updated: August 2, 2012
• Start date: November 2008
• Est. completion date: January 2011

Study information

• Verified date: August 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• LCL161

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of dose-limiting toxicities		Cycle 1	Yes
Secondary	Frequency and type of adverse events		throughout the study	Yes
Secondary	Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability)		3 months	Yes
Secondary	Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters)		4 weeks	No
Secondary	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	No
Secondary	Solid tumor response criteria will be used to identify any anti-tumor activity		After a minimum of 2 cycles	No

External Links

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