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COMPLETEDPHASE1/PHASE2

Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients

A Phase I Dose Escalation, Multi-center, Open-label Study of AUY922 Administered IV on a Once Weekly Schedule in Adult Patients With Advanced Solid Malignancies Including Phase II Expansion Arms in Patients With Either HER2 Positive or ER Positive Locally Advanced or Metastatic Breast Cancer.

NCT00526045•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II expansion arms will investigate efficacy in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer. Additional patients with advanced solid malignancies will also be investigated in a separate expansion arm. Safety, pharmacokinetics and pharmacodynamics will be assessed.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Dose-escalation and MTD dose expansion arm: Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists.
•Breast cancer phase II expansion arms only:
•1. Females patients with HER2 positive non-operable locally advanced or metastatic breast cancer must have:
•* History of trastuzumab resistance, defined as either local or systemic disease progression on treatment with at least 8 weeks of a trastuzumab containing regimen.
•* Received up to 3 prior anti HER2 based regimens (i.e. trastuzumab and/or lapatinib in combination with other agents) for metastatic disease
•* Patients who develop metastases while receiving adjuvant or neo-adjuvant trastuzumab are eligible.
•HER2 positive patients, tumor/s must demonstrate HER2 over-expression based on either:
•* Immunohistochemistry (IHC) at the 3+ level, or
•* IHC 2+ confirmed by fluorescence in-situ hybridization (FISH). Tumors tested by FISH must be positive by the specific FISH assay for the amplification of HER2.
•2. Female patients with ER positive non-operable locally advanced or metastatic breast cancer patients who received standard sequence lines of endocrine therapy and whose disease has progressed on at least one and up to 3 lines of endocrine and/or cytotoxic therapy for advanced disease.
+6 more criteria

Exclusion Criteria

•1. Patients with CNS metastasis which are:
•* Symptomatic or
•* Require treatment for symptom control and/or
•* Growing
•Note: patients without clinical signs or symptoms of CNS involvement are not required to have a CT/MRI of the brain
•2. Prior treatment with any HSP90 or HDAC inhibitor compound.
•3. Patient who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
•* Chemotherapy within 4 weeks
•* Radiotherapy within 4 weeks
•* Palliative radiotherapy: within 2 weeks
+13 more criteria

Locations (10)

UCLA/ University of California Los Angeles UCLA

Los Angeles, California, United States

Georgia Health Sciences University Med College of GA

Augusta, Georgia, United States

Dana Farber Cancer Institute StudyCoordinator:CAUY922A2101

Boston, Massachusetts, United States

Washington University School Of Medicine-Siteman Cancer Ctr Dept. of Siteman Cancer Ctr.

St Louis, Missouri, United States

Nevada Cancer Institute Clinical Trials Office

Las Vegas, Nevada, United States

MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med.Onc(2)

Houston, Texas, United States

Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3)

San Antonio, Texas, United States

Novartis Investigative Site

Groningen, Netherlands

Novartis Investigative Site

Bellinzona, Switzerland

Novartis Investigative Site

Sutton, United Kingdom

Key Dates

Start Date

July 1, 2007

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

December 17, 2020

Enrollment

117

ACTUAL participants

Conditions

Breast CancerHematologic Neoplasms

Interventions

AUY922 2 mg/m2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer