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A Phase Ib/II, Mulicenter, Study of LEE011 in Combination With LGX818 in Adult Patients With BRAF Mutant Melanoma.


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Locally Advanced or Metastatic BRAF Mutant Melanoma

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Trial Information

A Phase Ib/II, Mulicenter, Study of LEE011 in Combination With LGX818 in Adult Patients With BRAF Mutant Melanoma.


Inclusion Criteria:



- Age ≥18 years.

- Diagnosis of locally advanced or metastatic melanoma along with written
documentation of BRAF V600 mutation.

- ECOG performance status of 0 - 2.

- Patients enrolled into Phase Ib must have evidence of evaluable and/or measurable
disease as determined by RECIST v1.1.

- Patients enrolled into Phase II (BRAFi naïve and resistant) must have evidence of
measurable disease as determined by RECIST v1.1.

- Archival tumor tissue must be obtained for patients enrolled in Phase Ib and Phase II
arm 1a/b- BRAFi naïve patients. If an archival tumor tissue is not available, a fresh
tumor sample is acceptable.

- For patients enrolled in the phase II arm 2, patients must agree to undergo a fresh
tumor biopsy unless one was collected prior to study entry but at the time of disease
relapse from the most recent BRAFi treatment.

Exclusion Criteria:

- Symptomatic brain metastases.

- Symptomatic or untreated leptomeningeal disease.

- Patients with inadequate laboratory values during screening.

- In the phase II BRAFi naïve arms (1a/b), prior exposure to CDK4/6 inhibitor (e.g., PD
0332991)

- Impaired cardiac function or clinically significant cardiac diseases.

- Impairment of gastro-intestinal (GI) function or GI disease that may significantly
alter the absorption of LEE011 or LGX818.

- Patients with concurrent severe and/or uncontrolled concurrent medical conditions.

- Previous or concurrent malignancy.

- Major surgery < 2 weeks before starting study treatment

- Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities (Phase Ib)

Outcome Description:

Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818.

Outcome Time Frame:

Cycle 1 = 28 days

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLEE011X2105

NCT ID:

NCT01777776

Start Date:

May 2013

Completion Date:

December 2015

Related Keywords:

  • Locally Advanced or Metastatic BRAF Mutant Melanoma
  • Open-label dose escalation; BRAF inhibitor; LEE011; CDK4/6; LGX818; RAF kinase inhibitor; metastatic melanoma; BRAF; V600
  • Melanoma

Name

Location

Cancer Centers of the Carolinas CCC FarisGreenville, South Carolina  29605
Oregon Health & Science University Dept. of OHSU (3)Portland, Oregon  97239
Northwestern University Clinical Research Office (2)Chicago, Illinois  60611
University of California at Los Angeles UCLA 3Los Angeles, California  90095
University of Colorado Dept of OncologyAurora, Colorado  80045
Memorial Sloan Kettering Cancer Center Dept OncologyNew York, New York  10021
Duke University Medical Center SC-6Durham, North Carolina  27710
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State UniversityColumbus, Ohio  43210
University of California San Diego Dept of OncLa Jolla, California  92093-0658
Yale University School of Medicine dept of OncNew Haven, Connecticut  06520
Cancer Centers of Florida PA Cancer Centers of South FloridOcoee, Florida  *see dep*
Dartmouth Hitchcock Medical Center Dept OncLebanon, New Hampshire  03756
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept of OncologySeattle, Washington  98109-1023