Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab

December 6, 2020 updated by: Novartis Pharmaceuticals

A Phase Ib/II, Multi-center, Open-label Study to Evaluate the Efficacy of AUY922 in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer, That Has Progressed After or During at Least One Trastuzumab-containing Regimen

The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment (28 days) medically unacceptable dose limiting toxicity (DLT).

The phase II part of the trial will assess any potential effect on efficacy of adding AUY922 to Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+ breast cancer.

Both AUY922 and Trastuzumab will be administered as a weekly IV infusion. Treatment should be continued as long as the patient does not have disease progression and tolerates the treatment. The following reasons are examples of acceptable reasons for discontinuing the study; tumor progression (by RECIST, as assessed by the investigator), unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 1

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

  • France
      • Dijon Cedex, France, 21034
        • Novartis Investigative Site
      • Saint-Herblain Cédex, France, 44805
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Tuebingen, Germany, 72076
        • Novartis Investigative Site
  • Italy
    • PO
      • Prato, PO, Italy, 59100
        • Novartis Investigative Site
    • TO
      • Candiolo, TO, Italy, 10060
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119228
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28009
        • Novartis Investigative Site
    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
  • Sweden
      • Stockholm, Sweden, SE-171 76
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE1 5WW
        • Novartis Investigative Site
      • Manchester, United Kingdom, M20 2BX
        • Novartis Investigative Site
      • Oxford, United Kingdom, OX2 6HE
        • Novartis Investigative Site
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group Dept of Highlands Oncology Grp

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

All

Description

Inclusion Criteria:

  • Female patients with confirmed HER-2 positive , non-operable locally advanced or metastatic breast cancer
  • All patients must have received at least 1 but no more than 2 prior anti HER2 based regimens including at least 1 regimen containing Trastuzumab.
  • All patients must have at least one measurable lesion as defined by RECIST criteria.
  • All patients must have documented progressive disease following the last line of therapy before entering the study
  • ECOG Performance status ≤ 1

Exclusion Criteria:

  • Patients with known CNS metastasis which are: symptomatic or require treatment for symptom control and/or growing
  • Prior treatment with any HSP90 or HDAC inhibitor
  • Impaired cardiac function
  • Acute or chronic liver or renal disease
  • Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTc interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
  • Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline.

Other protocol-defined inclusion/exclusion criteria may apply

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AUY922 + Trastuzumab
Drug: Trastuzumab
Drug: AUY922

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab (phase lb)
Time Frame: 4 weeks
4 weeks
Overall Response Rate as assessed by RECIST (phase ll)
Time Frame: Every 8 weeks for the first 24 weeks and every 12 weeks thereafter
Every 8 weeks for the first 24 weeks and every 12 weeks thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess concentration of AUY922 and BJP762 in the blood at different time points (phase lb & ll)
Time Frame: 4 weeks
4 weeks
Assess frequency, intensity and duration of Adverse Events as a Measure of Safety and Tolerability (phase lb & ll)
Time Frame: average 6 months
average 6 months
Progression Free Survival (PFS) at the RPTD dose (phase ll only)
Time Frame: every 3 months until 24 months after the last patient has been enrolled
every 3 months until 24 months after the last patient has been enrolled
Overall Survival (OS) at the RPTD dose
Time Frame: every 3 months until 24 months after the last patient has been enrolled
every 3 months until 24 months after the last patient has been enrolled

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Investigative Site, Novartis Investigative Site

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

September 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

January 5, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUY922A2109
  • 2009-015628-27 (EudraCT Number)

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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