Safety and Efficacy of LCL161 in Patients With Solid Tumors
NCT ID: NCT01098838
Last Updated: 2012-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
71 participants
INTERVENTIONAL
2008-11-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Weekly dosing of LCL161
by mouth (oral)
LCL161
Comparison of LCL161
tablet versus liquid
LCL161
Twice daily dosing of LCL161
by mouth for 4 days followed by a 3-day rest period every week
LCL161
Interventions
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LCL161
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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CLCL161A2101
Identifier Type: -
Identifier Source: org_study_id