Safety and Efficacy of LCL161 in Patients With Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT01098838

Run by

Novartis Pharmaceuticals

People needed

71

Starts

2008-11-01

Expected to finish

2011-01-01

Last updated by the study team

2012-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2) — Chapel Hill, North Carolina, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2) — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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