Official Title
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)
Brief Summary

Continued access to treatment for subjects who continue benefit from therapy withgedatolisib 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.

Available
Intermediate-size Population
Breast Neoplasm Malignant Female

Drug: Gedatolisib

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

Inclusion Criteria:

1. Currently enrolled in the B2151009 clinical study and benefiting from treatment with
gedatolisib in combination with other therapies as determined by the Investigator

2. Previously demonstrated compliance and are willing and able to comply with scheduled
visits, treatment plans, and other study procedures

3. No evidence of progressive disease, as determined by the Investigator

4. Provide written informed consent prior to enrolling and receiving treatment

Exclusion Criteria:

1. Permanently discontinued from treatment in Study B2151009, or discontinued from
Study B2151009 for any reason

2. Women who are pregnant, intend to become pregnant, or nursing

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

University of Alabama at Birmingham
Birmingham, Alabama, United States

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

Seattle Cancer Care Alliance
Seattle, Washington, United States

Contacts

Nadene Zack, MS
844-310-3900
nzack@celcuity.com

NCT Number
MeSH Terms
Breast Neoplasms
Neoplasms
Gedatolisib