A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Phase 1 Completed 141 enrolled Celcuity Inc

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.

Timeline

Start: 2016-06-14
Primary completion: 2022-01-19
Completion: 2022-01-19

Publications

Layman RM, Han HS, Rugo HS, Stringer-Reasor EM, Specht JM, Dees EC, Kabos P, Suzuki S, Mutka SC, Sullivan BF, Gorbatchevsky I, Wesolowski R. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol. 2024 Apr;25(4):474-487. doi: 10.1016/S1470-2045(24)00034-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fulvestrant	Small molecule	500 mg	Intramuscular
Subject	Gedatolisib	Small molecule	180 mg	Intravenous
Subject	Letrozole	Other / unclassified	2.5 mg	—
Subject	Palbociclib	Small molecule	125 mg	—

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Summary

Timeline

Publications

Drugs

Indications