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Safety and Efficacy of LCL161 in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01098838
Recruitment Status : Completed
First Posted : April 5, 2010
Last Update Posted : August 3, 2012
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: LCL161 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors
Study Start Date : November 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: Weekly dosing of LCL161
by mouth (oral)
Drug: LCL161
Experimental: Comparison of LCL161
tablet versus liquid
Drug: LCL161
Experimental: Twice daily dosing of LCL161
by mouth for 4 days followed by a 3-day rest period every week
Drug: LCL161

Primary Outcome Measures :
  1. Occurrence of dose-limiting toxicities [ Time Frame: Cycle 1 ]

Secondary Outcome Measures :
  1. Frequency and type of adverse events [ Time Frame: throughout the study ]
  2. Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability) [ Time Frame: 3 months ]
  3. Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters) [ Time Frame: 4 weeks ]
  4. 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 [ Time Frame: Intermittent throughout treatment period ]
  5. Solid tumor response criteria will be used to identify any anti-tumor activity [ Time Frame: After a minimum of 2 cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01098838

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United States, North Carolina
UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2)
Chapel Hill, North Carolina, United States, 27599-7295
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Tennessee
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01098838    
Other Study ID Numbers: CLCL161A2101
First Posted: April 5, 2010    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
solid tumor
programmed cell death
Additional relevant MeSH terms:
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