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NCT00626106 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00626106
Other study ID # 20060362
Secondary ID QUILT-2.015
Status Completed
Phase Phase 2
First received February 21, 2008
Last updated October 26, 2016
Start date March 2008
Est. completion date August 2011

Study information
Verified date October 2016
Source NantCell, Inc.
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und ImpfstoffeAustralia: Therapeutic Goods AdministrationCanada: Health CanadaIreland: Irish Medicines BoardSpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: Swissmedic (Swiss Agency for Therapeutic Products)United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationUnited States: Western Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date August 2011
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 2 - placebo with exemestane or fulvestrant
• AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant
• AMG 479 or placebo administered with either exemestane or fulvestrant
Arm 1 - AMG 479 administered with exemestane or fulvestrant

Locations
Country Name City State
Australia Research Site Footscray Victoria
Australia Research Site Geelong Victoria
Australia Research Site Malvern Victoria
Australia Research Site Waratah New South Wales
Australia Research Site Woodville South South Australia
Canada Research Site Montreal Quebec
Canada Research Site Ottawa Ontario
Canada Research Site Sault Ste. Marie Ontario
Canada Research Site Toronto Ontario
Canada Research Site Vancouver British Columbia
France Research Site Dijon
France Research Site Le Mans
France Research Site Lyon
France Research Site Montpellier Cedex 5
France Research Site Nice Cedex 2
France Research Site Paris Cedex 5
France Research Site Reims Cedex
France Research Site Saint Herblain
Germany Research Site Frankfurt
Germany Research Site Frankfurt
Germany Research Site Hannover
Germany Research Site München
Ireland Research Site Dublin
Ireland Research Site Dublin
Spain Research Site Barcelona Cataluña
Spain Research Site L'Hospitalet de Llobregat Cataluña
Spain Research Site Madrid
Spain Research Site Sabadell Cataluña
Switzerland Research Site Chur
Switzerland Research Site Luzern 16
Switzerland Research Site Zurich
United Kingdom Research Site Derby
United Kingdom Research Site London
United Kingdom Research Site Manchester
United Kingdom Research Site Peterborough
United States Research Site American Fork Utah
United States Research Site Anaheim California
United States Research Site Atlanta Georgia
United States Research Site Beverly Hills California
United States Research Site Boca Raton Florida
United States Research Site Boynton Beach Florida
United States Research Site Chandler Arizona
United States Research Site Chicago Illinois
United States Research Site Concord California
United States Research Site Coral Springs Florida
United States Research Site Denville New Jersey
United States Research Site Duarte California
United States Research Site Gainesville Florida
United States Research Site Hershey Pennsylvania
United States Research Site High Point North Carolina
United States Research Site Lake Worth Florida
United States Research Site Lebanon New Hampshire
United States Research Site Marietta Georgia
United States Research Site Memphis Tennessee
United States Research Site Montebello California
United States Research Site Pittsburgh Pennsylvania
United States Research Site San Francisco California
United States Research Site Stamford Connecticut
United States Research Site Sylmar California
United States Research Site Tacoma Washington

Sponsors (1)
Lead Sponsor Collaborator
NantCell, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Ireland,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Robertson JF, Ferrero JM, Bourgeois H, Kennecke H, de Boer RH, Jacot W, McGreivy J, Suzuki S, Zhu M, McCaffery I, Loh E, Gansert JL, Kaufman PA. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. Lancet Oncol. 2013 Mar;14(3):228-35. doi: 10.1016/S1470-2045(13)70026-3. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Progression free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors criteria (modified RECIST) per local review 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 No
Secondary Incidence of adverse events, abnormal laboratory values, and anti-AMG 479 antibody formation 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 No
Secondary PK parameters of AMG 479 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 No
Secondary Breast cancer related symptoms, health related quality of life, and skin toxicity burden 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 No
Secondary 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 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 No
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