Continued access to treatment for subjects who continue benefit from therapy withgedatolisib in combination with palbociclib, and fulvestrant or letrozole.
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.
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.
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
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764, United States
University of Michigan
Ann Arbor 4984247, Michigan 5001836, United States
Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418, United States
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286, United States
Seattle Cancer Care Alliance
Seattle 5809844, Washington 5815135, United States
Nadene Zack, MS
844-310-3900
nzack@celcuity.com