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NCT05134922
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
trial testing Gedatolisib in Breast Neoplasm Malignant Female. Available.
Quick facts
| Lead sponsor | Celcuity Inc |
|---|---|
| Status | AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Gedatolisib (gedatolisib) — full drug profile →
Conditions studied
- Breast Neoplasm Malignant Female — all drugs for Breast Neoplasm Malignant Female →
Sponsor
Celcuity Inc — full company profile →
Who can join
18 and older, female only, with Breast Neoplasm Malignant Female. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05134922
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gedatolisib
Trials testing the same drug.
- NCT05501886 — Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced · Phase 3 · active not recruiting
- NCT03400254 — Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") · Phase 1, PHASE2 · withdrawn
- NCT03675893 — RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Can · Phase 2 · recruiting
- NCT03243331 — An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer · Phase 1 · completed
- NCT02920450 — Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) · Phase 1, PHASE2 · terminated
Other recruiting trials for Breast Neoplasm Malignant Female
Currently open trials in the same condition.
- NCT07162675 — Step Count and Treatment Response in Neoadjuvant Breast Cancer · recruiting
- NCT06938724 — Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer · Phase 2 · recruiting
- NCT05941299 — Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy · NA · recruiting
- NCT04424732 — SBRT for Breast Cancer Oligometastases · NA · recruiting
Other Celcuity Inc trials
Trials by the same sponsor.
- NCT06757634 — Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer · Phase 3 · recruiting
- NCT05501886 — Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced · Phase 3 · active not recruiting
- NCT02684032 — A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Pal · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05134922 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Celcuity Inc
- Last refreshed: 21 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05134922.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing