This study is not accepting new patients

Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

a study on Lung Cancer Non-Small Cell Lung Cancer Thyroid Cancer Colon Cancer Colorectal Cancer Breast Cancer Pancreatic Cancer Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
Principal Investigator
by Lyudmila Bazhenova (ucsd)Alain Algazi (ucsf)
Headshot of Lyudmila Bazhenova
Lyudmila Bazhenova
Headshot of Alain Algazi
Alain Algazi

Description

Summary

Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Details

N/A for expanded access

Keywords

Non Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Breast Cancer, Pancreatic Cancer, Papillary Thyroid Cancer, Other Solid Tumors With Evidence of Activating RET Alteration, Thyroid Neoplasms, Thyroid Diseases, Selpercatinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of cancer with RET activation, who are not eligible for an ongoing selpercatinib clinical trial and are medically suitable for treatment with selpercatinib
  • Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
  • Have adequate organ function

You CAN'T join if...

  • Currently enrolled in an ongoing clinical study of selpercatinib or another RET inhibitor
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds

Locations

  • University of California - San Diego not accepting new patients
    San Diego California 92103 United States
  • Univ of California San Francisco not accepting new patients
    San Francisco California 94115 United States
  • Irvine Medical Center not accepting new patients
    Orange California 92868 United States
  • City of Hope National Medical Center not accepting new patients
    Duarte California 91010-0269 United States

Lead Scientists at University of California Health

  • Lyudmila Bazhenova (ucsd)
    Dr. Bazhenova’s clinical practice and research concentrate on lung cancer, particularly as this relates to females and non-smokers. She actively participates in cooperative group trials, and takes an active role in designing and implementing clinical investigations, including phase II studies and correlative science projects with several UCSD investigators.
  • Alain Algazi (ucsf)
    Dr. Alain Algazi is a specialist in medical treatment – such as chemotherapy and immunotherapy – for patients with head and neck cancers, including head and neck squamous cell carcinoma, thyroid cancers and salivary gland cancers. He leads UCSF's program in medical therapy for head and neck cancers, and chairs the head and neck cancer research committee.

Details

Status
not accepting new patients
Start Date
Sponsor
Loxo Oncology, Inc.
ID
NCT03906331
Study Type
Expanded Access
Last Updated