West Cancer Center

MOLECULARLY TARGETED: Metastatic; >/= 2nd line; CDK4/6 pathway activation: "SIGNATURE CLEE011XUS03"

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 8- LEE011 for patients with CDK4/6 pathway activated tumors

Title

Novartis CLEE011XUS03

Study Title

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 8- LEE011 for patients with CDK4/6 pathway activated tumors

Site Link

NCT02187783

Malignancy

y- Colorectal, Ovarian, Gastric, Kidney, Leukemia, Lymphoma, Head and Neck, Breast Cancer, Esophagus, Liver, Bladder

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

No further standard therapies

Investigational Agent

LEE011

Drug Class

CDK4/6 Inhibitor

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/study/NCT02187783

Key Eligibility Criteria Details

Any of the following molecular alterations
CDK4 amplification or mutation
CDK6 amplification or mutation
Cyclin D1 (CCND1) amplification
Cyclin D2 (CCND3) amplifcation
p16 (CDKN2A) mutationNone of the following malignancies:
ER/PR or HER2 positive breast cancer (TNBC only allowed)
Sarcoma (Eligible but cohort on hold)
Lung Cancer (Eligible but cohort on hold)
liposarcoma
prostate cancer
melanoma
teratoma
mantle cell lymphoma_
ECOG PS 0-1
No CNS involvement
At least one prior metastatic therapy
No expectation that further therapy will result in durable remission

Objective

Primary- Clinical Benefit Rate; Secondary- ORR, PFS, OS, DoR, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

CDK4/6, cyclin D1/3, or p16 aberrations

Dosing Frequency

LEE011 600mg PO qday 3 wks on/ 1 wk off

Control Agents

N/A

Study Protocol

Randomized