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OpenTrials
Completed

NCT Number: NCT01098838

Safety and Efficacy of LCL161 in Patients With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2), Chapel Hill, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCL161

Drug

Primary outcomes

  1. Occurrence of dose-limiting toxicities

    Time frame: Cycle 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 5, 2010
Registry last updated
Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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