Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Celcuity

Status

Conditions: Breast Neoplasm Malignant Female

Treatments: Drug: Gedatolisib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05134922

CELC-G-001

Details and patient eligibility

About

Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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