QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

October 26, 2016 updated by: NantCell, Inc.

An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Research Site
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Research Site
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Research Site
      • Geelong, Victoria, Australia, 3220
        • Research Site
      • Malvern, Victoria, Australia, 3144
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
  • France
      • Dijon, France, 21079
        • Research Site
      • Le Mans, France, 72000
        • Research Site
      • Lyon, France, 69008
        • Research Site
      • Montpellier Cedex 5, France, 34298
        • Research Site
      • Nice Cedex 2, France, 06182
        • Research Site
      • Paris Cedex 5, France, 75248
        • Research Site
      • Reims Cedex, France, 51056
        • Research Site
      • Saint Herblain, France, 44800
        • Research Site
  • Germany
      • Frankfurt, Germany, 60590
        • Research Site
      • Frankfurt, Germany, 65929
        • Research Site
      • Hannover, Germany, 30177
        • Research Site
      • München, Germany, 80637
        • Research Site
  • Ireland
      • Dublin, Ireland, 4
        • Research Site
      • Dublin, Ireland, 8
        • Research Site
  • Spain
      • Madrid, Spain, 28040
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
        • Research Site
      • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
        • Research Site
      • Sabadell, Cataluña, Spain, 08208
        • Research Site
  • Switzerland
      • Chur, Switzerland, 7000
        • Research Site
      • Luzern 16, Switzerland, 6000
        • Research Site
      • Zurich, Switzerland, 8032
        • Research Site
  • United Kingdom
      • Derby, United Kingdom, DE22 3DT
        • Research Site
      • London, United Kingdom, W6 8RF
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Peterborough, United Kingdom, PE3 9GZ
        • Research Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Beverly Hills, California, United States, 90211
        • Research Site
      • Concord, California, United States, 94520
        • Research Site
      • Duarte, California, United States, 91010
        • Research Site
      • Montebello, California, United States, 90640
        • Research Site
      • San Francisco, California, United States, 94115
        • Research Site
      • Sylmar, California, United States, 91342
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Research Site
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Research Site
      • Boynton Beach, Florida, United States, 33435
        • Research Site
      • Coral Springs, Florida, United States, 33065
        • Research Site
      • Gainesville, Florida, United States, 32605
        • Research Site
      • Lake Worth, Florida, United States, 33467
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
      • Marietta, Georgia, United States, 30060
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Research Site
    • New Jersey
      • Denville, New Jersey, United States, 07834
        • Research Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Research Site
    • Utah
      • American Fork, Utah, United States, 84003
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed carcinoma of the breast with locally advanced or metastatic disease
  • Confirmation of hormone receptor (HR) positive disease status
  • Amenable to receive endocrine therapy
  • Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer
  • Postmenopausal woman ≥ 18 years old

Exclusion Criteria:

  • HR-unknown or HR-negative disease
  • Not amenable to endocrine therapy
  • Central nervous system metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 2 - placebo with exemestane or fulvestrant
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 1 - AMG 479 administered with exemestane or fulvestrant
Active Comparator: Investigational Product
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 2 - placebo with exemestane or fulvestrant
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 1 - AMG 479 administered with exemestane or fulvestrant
Other: Roll-over
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 2 - placebo with exemestane or fulvestrant
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant
Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 1 - AMG 479 administered with exemestane or fulvestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors criteria (modified RECIST) per local review
Time Frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events, abnormal laboratory values, and anti-AMG 479 antibody formation
Time Frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
PK parameters of AMG 479
Time Frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
Breast cancer related symptoms, health related quality of life, and skin toxicity burden
Time Frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
Clin benefit(complete/partial response,or stable disease≥24 wks per modified RECIST/local review),objective response rate(complete/partial response per modified RECIST/local review),duration of response,TTP,time-to-response,time-to-tx failure,survival
Time Frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NantCell, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060362
  • QUILT-2.015 (Other Identifier: NantCell, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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