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Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer

NCT02599714 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-06-06

No results posted yet for this study

Summary

This dose finding/extension study was designed originally to consist of three parts: Part A was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of fulvestrant (referred to as the triplet) in postmenopausal women with locally advanced/ metastatic estrogen receptor positive (ER+) breast cancer. Part B was to further characterize safety, tolerability, PK, and preliminary efficacy in single-arm dose expansion groups. Part C was to be a Phase 2, randomized, double-blind, extension comparing the triplet and doublet combinations. Part C was deleted from the protocol and was not performed.

Conditions

  • Advanced and Metastatic Breast Cancer

Interventions

DRUG

AZD2014

The triplet combination will be comprised of AZD2014 + palbociclib + fulvestrant.

DRUG

Palbociclib

cyclin dependent kinase inhibitor

DRUG

Fulvestrant

Fulvestrant hormonal therapy as background

Sponsors & Collaborators

Principal Investigators

  • Anja Wiliams · Sarah Cannon Research Institute UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-07
Primary Completion
2018-03-30
Completion
2023-11-23
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02599714 on ClinicalTrials.gov