Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

March 19, 2025 updated by: Celcuity Inc

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)

Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Available
        • University of Alabama at Birmingham
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Available
        • University of Michigan
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Available
        • Ohio State University Comprehensive Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Available
        • The University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Available
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator
  2. Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures
  3. No evidence of progressive disease, as determined by the Investigator
  4. Provide written informed consent prior to enrolling and receiving treatment

Exclusion Criteria:

  1. Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason
  2. Women who are pregnant, intend to become pregnant, or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celcuity Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 14, 2021

First Submitted That Met QC Criteria

November 14, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELC-G-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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