Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
ConditionBreast Neoplasm Malignant Female
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexFemale
Age18+
SponsorCelcuity Inc
About this trial
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
Gedatolisib
DrugGedatolisib is a potent, reversible dual inhibitor that selectively targets phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in biochemical and cellular assays.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov