Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Sponsor: Celcuity Inc

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05134922

Patient View

This study provides continued access to gedatolisib for subjects benefiting from its combination with palbociclib, and fulvestrant or letrozole. Eligible participants must be from the B2151009 study, compliant, and without disease progression. Exclusions include those who discontinued B2151009 or are pregnant. Gedatolisib targets PI3K and mTOR pathways.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

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