Expanded Access Protocol for Subjects Previously Treated... | NCT05134922

Studies
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

NCT05134922

Sponsor

Celcuity Inc

Status

Available

Last Update Posted

Mar 21, 2025Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Breast Neoplasm Malignant Female

Interventions

Gedatolisib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 14, 2021

First Submission Date that Met QC Criteria

Nov 14, 2021

First Posted Date

Nov 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2025

Last Update Posted Date

Mar 21, 2025Actual

Description Module

Brief Summary

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

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Intermediate-type Population

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gedatolisib	Drug	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 Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nadene Zack, MS	Contact	844-310-3900		nzack@celcuity.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham	Available	Birmingham	Alabama	35233	United States