Clinical trial · Expanded Access
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)
NCT05134922CI-TRIAL-00087517availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Malignant Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gedatolisib | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.