Expanded Access Program for Patients Previously Treated with Gedatolisib in Study B2151009
Sponsor: Celcuity Inc
ClinicalTrials ID:NCT05134922
This program allows patients who are benefiting from the treatment with gedatolisib, in combination with other medications, to continue receiving it. The treatment includes palbociclib and either fulvestrant or letrozole.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The main goal of this program is to provide ongoing access to the treatment for patients who are experiencing positive effects from gedatolisib, combined with palbociclib and either fulvestrant or letrozole. This is for patients who were part of the B2151009 study and continue to benefit from the therapy.
Description
This program is designed to allow patients who have been part of the B2151009 study and are benefiting from the treatment with gedatolisib, in combination with palbociclib and either fulvestrant or letrozole, to continue their treatment. The focus is on maintaining access to the therapy for those who are seeing positive results.
Eligibility Criteria
Inclusion Criteria
- Currently participating in the B2151009 study and benefiting from the treatment with gedatolisib and other medications, as determined by the doctor.
- Have shown the ability to follow the study schedule and treatment plan.
- No signs of the disease getting worse, as determined by the doctor.
- Willing to provide written consent to continue with the treatment.
Exclusion Criteria
- Have permanently stopped treatment in the B2151009 study or left the study for any reason.
- Women who are pregnant, planning to become pregnant, or are breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35233 | Birmingham | Alabama |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
| Seattle Cancer Care Alliance | 98109 | Seattle | Washington |
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