TRIAL DETAIL

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

Drug:
Trial Name:
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
NCT#:
Conditions:
Solid Tumors
Status:
Ongoing, but not recruiting
Phase:
2
Start Date 08/01/2014
Age of Trial (yrs) 10.4
Treatment Phase:
Gleevec-resistant
Drug Category:
Cdk4 & Cdk6 inhibitor
Strategy:
Block related tumor signal paths
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
CLEE011XUS03
Sponsor:
Novartis
Patient Contact:
Novartis Pharmaceuticals 1-888-669-6682 Enrollment Call Center 1-855-744-6727
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Inclusion Criteria (partial):

Patient has a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative will be included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).
Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation
Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.

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Trial Results
 
 

Drug Information
Novartis sneaks up on Pfizer with CDK4/6 cancer challenger
 
Novartis website drug page
 

Trial Sites

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