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
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Drug: LCL161
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Occurrence of dose-limiting toxicities [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 71
Study Start Date: November 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098838

Locations
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01098838     History of Changes
Other Study ID Numbers: CLCL161A2101
Study First Received: April 1, 2010
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Cancer
adults
solid tumor
apoptosis
programmed cell death
LCL161

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014