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

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of dose-limiting toxicities

Outcome Time Frame:

Cycle 1

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

January 2011

Related Keywords:

  • Advanced Solid Tumors
  • Cancer
  • adults
  • solid tumor
  • apoptosis
  • programmed cell death
  • LCL161
  • Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2) Chapel Hill, North Carolina  27599-7295
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2) Nashville, Tennessee  37203