Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
completion

Description

Summary

The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.

Official 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

Keywords

Tumors With CDK4/6 Pathway Activation Solid malignancy Hematologic malignancy Mutations Amplifications Signature CDK4 CDK6 CDK4/6 Cyclin D1 CCND, Cyclin D3 p16 mutation CDKN2A LEE011 Breast cancer Ovarian cancer Lymphoma Mesothelioma Pancreatic neuroendocrine Leukemia Tumor Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient had a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative was 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 had 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.
  • Patient had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
  • Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

You CAN'T join if...

  • Patients had received prior treatment with LEE011.
  • Patient had clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
  • Patients had primary CNS tumor or CNS tumor involvement
  • Patient had received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Locations

  • University of California Davis Cancer Center UC Davis Cancer (3)
    Sacramento California 95817 United States
  • PCR Oncology
    Pismo Beach California 93449 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Novartis Pharmaceuticals
Links
http://www.signaturetrial.com/
Sign up for this study
ID
NCT02187783
Phase
Phase 2
Study Type
Interventional
Last Updated