Back to resultsExpanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
Primary Purpose
Breast Neoplasm Malignant Female
Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Gedatolisib
Sponsored by
About this trial
This is an expanded access trial for Breast Neoplasm Malignant Female
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
- University of Michigan
- Ohio State University Comprehensive Cancer Center
- The University of Texas MD Anderson Cancer Center
- Seattle Cancer Care Alliance
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05134922
Brief Title
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
Official Title
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celcuity, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Malignant Female
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gedatolisib
Intervention Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadene Zack, MS
Phone
844-310-3900
Email
nzack@celcuity.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Stringer-Reasor, MD
Email
esreasor@uabmc.edu
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne F Schott, MD
Phone
734-936-6266
Email
aschott@med.umich.edu
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Weslowski, MD
Email
robert.wesolowski@osumc.edu
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Layman, MD
Email
rlayman@mdanderson.org
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Specht, MD
Phone
206-606-6768
Email
jspecht@uw.edu
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
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