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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

NCT02684032 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2022-07-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gedatolisib

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

DRUG

Palbociclib

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

DRUG

Letrozole

Letrozole at 2.5 mg daily

DRUG

Fulvestrant

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

Sponsors & Collaborators

  • Celcuity Inc

    lead INDUSTRY

Principal Investigators

  • Igor Gorbatchevsky, MD · Celcuity Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02684032 on ClinicalTrials.gov