Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
- Conditions
- Breast Neoplasm Malignant Female
- Registration Number
- NCT05134922
- Lead Sponsor
- Celcuity Inc
- Brief Summary
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
- 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.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- Female
- Target Recruitment
- Not specified
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 & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States