Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab
NCT ID: NCT01271920
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2010-09-30
2013-10-31
Brief Summary
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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unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AUY922 + Trastuzumab
AUY922
Trastuzumab
Interventions
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AUY922
Trastuzumab
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis Investigative Site
Role: STUDY_DIRECTOR
Novartis Investigative Site
Locations
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Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
Novartis Investigative Site
Dijon, , France
Novartis Investigative Site
Saint-Herblain Cédex, , France
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novartis Investigative Site
Prato, PO, Italy
Novartis Investigative Site
Candiolo, TO, Italy
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Stockholm, , Sweden
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Leicester, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Novartis Investigative Site
Oxford, , United Kingdom
Countries
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References
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Kong A, Rea D, Ahmed S, Beck JT, Lopez Lopez R, Biganzoli L, Armstrong AC, Aglietta M, Alba E, Campone M, Hsu Schmitz SF, Lefebvre C, Akimov M, Lee SC. Phase 1B/2 study of the HSP90 inhibitor AUY922 plus trastuzumab in metastatic HER2-positive breast cancer patients who have progressed on trastuzumab-based regimen. Oncotarget. 2016 Jun 21;7(25):37680-37692. doi: 10.18632/oncotarget.8974.
Related Links
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Results for CAUY922A2109 can be found on the Novartis Clinical Trials Results Website
Other Identifiers
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2009-015628-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAUY922A2109
Identifier Type: -
Identifier Source: org_study_id