- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05134922
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
August 28, 2023 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 Contact
- Name: Nadene Zack, MS
- Phone Number: 844-310-3900
- Email: nzack@celcuity.com
Study Locations
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Alabama
-
Birmingham, Alabama, United States, 35233
- Available
- University of Alabama at Birmingham
-
Contact:
- Erica Stringer-Reasor, MD
- Email: esreasor@uabmc.edu
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- Available
- University of Michigan
-
Contact:
- Anne F Schott, MD
- Phone Number: 734-936-6266
- Email: aschott@med.umich.edu
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-
Ohio
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Columbus, Ohio, United States, 43210
- Available
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Robert Weslowski, MD
- Email: robert.wesolowski@osumc.edu
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-
Texas
-
Houston, Texas, United States, 77030
- Available
- The University of Texas MD Anderson Cancer Center
-
Contact:
- Rachel Layman, MD
- Email: RLayman@mdanderson.org
-
-
Washington
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Seattle, Washington, United States, 98109
- Available
- Seattle Cancer Care Alliance
-
Contact:
- Jennifer Specht, MD
- Phone Number: 206-606-6768
- Email: jspecht@uw.edu
-
-
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:
- Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator
- Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures
- No evidence of progressive disease, as determined by the Investigator
- Provide written informed consent prior to enrolling and receiving treatment
Exclusion Criteria:
- Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason
- 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
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)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
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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