Upstate Active Clinical Trials

Study Title:

EAY191-N5: A RANDOMIZED TRIAL OF NERATINIB, A PAN-ERBB INHIBITOR, ALONE OR IN COMBINATION WITH PALBOCICLIB, A CDK4/6 INHIBITOR, IN PATIENTS WITH HER2+ GYNECOLOGIC CANCERS AND OTHER SOLID TUMORS
A ComboMATCH Treatment Trial

What is the purpose of the study? (in Layman's terms, please describe the study)

This study is being done to answer the following question: Will the combination of neratinib and palbociclib be more effective in delaying growth and/or spread of cancer than neratinib alone? We are doing this study because we want to find out if neratinib with palbociclib is better than neratinib alone for HER2+ gynecologic cancers and other solid tumors.

Upstate Institutional Review Board (IRB) Number:

2174467

Study/Protocol ID:

EAY191-N5

Study Phase:

ll

Patient Age Group:

Adults

Principal Investigator:

Mary J Cunningham, MD

What is involved if I participate?

• How long is the study?
  5 years
• Is transportation provided or reimbursed?
  No
• Is parking provided or reimbursed?
  No
• What tests and procedures are involved?
  Complete blood count with differential, Comprehensive metabolic panel, Electrocardiogram and 2D echo or MUGA scan, Pregnancy test if clinically indicated. CA125, Radiographic Tumor Measurement, Biopsy if no archival tissue is available from within 12 months.

Where will the study take place?

SUNY Upstate Medical University Hospital Cancer Center, Upstate Gyn Oncology at Madison Irving.

Other Information:

Testing the use of neratinib or the combination of neratinib and palbociclib targeted treatment for HER2+ gynecologic and other solid tumors.

ClinicalTrials.Gov ID:

NCT06126276

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Sonia Masood
Phone: 315-464-8232
Email: [email protected]

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