Clinical Trials Directory

Trials / Completed

CompletedNCT02684032

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 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)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
141 (actual)
Sponsor
Celcuity Inc · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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

Conditions

Interventions

TypeNameDescription
DRUGGedatolisibGedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
DRUGPalbociclibPalbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
DRUGLetrozoleLetrozole at 2.5 mg daily
DRUGFulvestrantFulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.

Timeline

Start date
2016-06-14
Primary completion
2022-01-19
Completion
2022-01-19
First posted
2016-02-17
Last updated
2022-07-27

Locations

41 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02684032. Inclusion in this directory is not an endorsement.