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

• ClinicalTrials.gov Identifier: NCT00626106
• Recruitment Status: Completed
• First Posted: February 29, 2008
• Last Update Posted: October 27, 2016
• Sponsor: NantCell, Inc.
• Information provided by (Responsible Party): NantCell, Inc.

Tracking Information

• First Submitted Date: February 21, 2008
• First Posted Date: February 29, 2008
• Last Update Posted Date: October 27, 2016
• Study Start Date: March 2008
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 6, 2008): 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 ]
• Original Primary Outcome Measures (submitted: February 21, 2008): Progression free survival (PFS) [ Time Frame: Four to six months ]

Current Secondary Outcome Measures (submitted: April 1, 2010)

• 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 ]
• 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 ]
• 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 ]
• 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 ]

Original Secondary Outcome Measures (submitted: February 21, 2008)

• safety and tolerability [ Time Frame: Throughout study participants duration ]
• Pharmacokinetics of study treatment [ Time Frame: Before and/or after study treatment administration throughout study participants duration ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Breast Cancer
• Breast Tumors
• Metastatic Cancer

Intervention

• 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

Study Arms

• Placebo Comparator: Placebo
  Intervention: Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
• Active Comparator: Investigational Product
  Intervention: Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
• Roll-over
  Intervention: Drug: AMG 479 or placebo administered with either exemestane or fulvestrant

• Publications *: 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. Epub 2013 Feb 13.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 1, 2009): 156
• Original Estimated Enrollment (submitted: February 21, 2008): 150
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, France, Germany, Ireland, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT00626106
• Other Study ID Numbers: 20060362; QUILT-2.015 ( Other Identifier: NantCell, Inc. )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: NantCell, Inc.
• Original Responsible Party: Global Development Leader, Amgen Inc.
• Current Study Sponsor: NantCell, Inc.
• Original Study Sponsor: Amgen
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: NantCell, Inc.
• Verification Date: October 2016