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Safety and Efficacy of LCL161 in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01098838
First received: April 1, 2010
Last updated: August 2, 2012
Last verified: August 2012
History of Changes

April 1, 2010
August 2, 2012
November 2008
January 2011   (final data collection date for primary outcome measure)
Occurrence of dose-limiting toxicities [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01098838 on ClinicalTrials.gov Archive Site
  • Frequency and type of adverse events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Solid tumor response criteria will be used to identify any anti-tumor activity [ Time Frame: After a minimum of 2 cycles ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of LCL161 in Patients With Solid Tumors
A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: LCL161
  • Experimental: Weekly dosing of LCL161
    by mouth (oral)
    Intervention: Drug: LCL161
  • Experimental: Comparison of LCL161
    tablet versus liquid
    Intervention: Drug: LCL161
  • Experimental: Twice daily dosing of LCL161
    by mouth for 4 days followed by a 3-day rest period every week
    Intervention: Drug: LCL161
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01098838
CLCL161A2101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP