NCT01098838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2008

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

August 3, 2012

Status Verified

August 1, 2012

Enrollment Period

2.2 years

First QC Date

April 1, 2010

Last Update Submit

August 2, 2012

Conditions

Advanced Solid Tumors

Keywords

Canceradultssolid tumorapoptosisprogrammed cell deathLCL161

Outcome Measures

Primary Outcomes (1)

  • Occurrence of dose-limiting toxicities

    Cycle 1

Secondary Outcomes (5)

  • Frequency and type of adverse events

    throughout the study

  • Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability)

    3 months

  • Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters)

    4 weeks

  • 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

    Intermittent throughout treatment period

  • Solid tumor response criteria will be used to identify any anti-tumor activity

    After a minimum of 2 cycles

Study Arms (3)

Weekly dosing of LCL161

EXPERIMENTAL

by mouth (oral)

Drug: LCL161

Comparison of LCL161

EXPERIMENTAL

tablet versus liquid

Drug: LCL161

Twice daily dosing of LCL161

EXPERIMENTAL

by mouth for 4 days followed by a 3-day rest period every week

Drug: LCL161

Interventions

LCL161DRUG
Comparison of LCL161Twice daily dosing of LCL161Weekly dosing of LCL161

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2)

Chapel Hill, North Carolina, 27599-7295, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • 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.

    PMID: 25113756DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

LCL161

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 5, 2010

Study Start

November 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

August 3, 2012

Record last verified: 2012-08

Locations

US(3)