CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 141 enrolled
Drug / intervention
Gedatolisib +3 moredrug
Likely dose
Gedatolisib 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02684032
NCT02684032Phase 1Completed
CompareCT.gov

PHASE 1B STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND CLINICAL ACTIVITY OF GEDATOLISIB IN COMBINATION WITH PALBOCICLIB AND EITHER LETROZOLE OR FULVESTRANT IN WOMEN WITH METASTATIC OR LOCALLY ADVANCED/RECURRENT BREAST CANCER (MBC)

Celcuity Inc·interventional·Posted Feb 17, 2016·Updated Jul 27, 2022

In Brief

A Phase 1 clinical trial evaluating Gedatolisib, Palbociclib, and 2 other interventions for Breast Cancer. Completed, enrolled 141 participants across 41 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 17, 2016
Enrollment StartJun 14, 2016
Primary CompletionJan 19, 2022
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 10.4 years ago

Interventions

Gedatolisibdrug

Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.

Palbociclibdrug

Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.

Letrozoledrug

Letrozole at 2.5 mg daily

Fulvestrantdrug

Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.