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A Phase Ib Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase Ib Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors

Inclusion Criteria:

Patients with breast cancer must have a histologically or cytologically confirmed
diagnosis of disease that has metastasized or is resistant to therapy.

Patients with ovarian cancer must have histological evidence of recurrent epithelial
ovarian, fallopian tube or peritoneal cancer.

Tumor must be positive for the gene expression signature Patients must have recovered or
stabilized from all toxicities related to their previous treatment except for alopecia
Male or female patients 18 years or older ECOG performance status 0-1 Life expectancy
greater than 12 weeks Measurable disease as determined by RECIST v1.0 Patients must give
written informed consent and comply with the protocol

Exclusion Criteria:

For patients with breast cancer:

Concurrent Her2-directed or anti-estrogen therapy

For patients with ovarian cancer:

Primary refractory disease, defined as progression during initial treatment with a
platinum- and taxane-containing regimen.

Prior treatment with weekly paclitaxel. More than two chemotherapy regimens given in the
relapse setting. Evidence of a documented bowel obstruction within six months of study
entry Patients with unresolved peripheral neuropathy, nausea, vomiting, or diarrhea ≥
CTCAE Grade 2 Any concurrent severe and/or uncontrolled medical conditions that could
increase the patient's risk for toxicity while in the study or that could confound
discrimination between disease- and study treatment-related toxicities.

Patients with impairment of GI function or GI disease that may significantly alter the
absorption of LCL161 Patients who have undergone major surgery ≤ 3 weeks prior to starting
study drug or who have not recovered from side effects of procedure.

Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a positive
β-HCG laboratory test (> 5 mIU/mL).

Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active
hepatitis B or C (HIV and hepatitis testing are not mandatory).

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

July 2014

Related Keywords:

  • Solid Tumors
  • LCL161
  • solid tumors
  • paclitaxel
  • Neoplasms



Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2) Nashville, Tennessee  37203
Dana Farber Cancer Institute SC Boston, Massachusetts  02115
University of North Carolina Lineberger Comp Cancer Ctr Chapel Hill, North Carolina  27514