Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
1 other identifier
expanded_access
N/A
1 country
5
Brief Summary
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
5 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2021
CompletedFirst Posted
Study publicly available on registry
November 26, 2021
CompletedMarch 21, 2025
March 1, 2025
November 14, 2021
March 19, 2025
Conditions
Interventions
Gedatolisib is a potent, reversible dual inhibitor that selectively targets phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in biochemical and cellular assays.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celcuity Inclead
Study Sites (5)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2021
First Posted
November 26, 2021
Last Updated
March 21, 2025
Record last verified: 2025-03