Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Breast Neoplasm Malignant Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT05134922
• Other study ID #: CELC-G-001
• Status: Available

Study information

• Verified date: August 2023
• Source: Celcuity, Inc.
• Contact: Nadene Zack, MS
• Phone: 844-310-3900
• Email: nzack[@]celcuity.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Malignant Female
• Breast Neoplasms
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
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

Sponsors (1)

Lead Sponsor	Collaborator
Celcuity, Inc.

Country where clinical trial is conducted

United States,