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
NCT ID: NCT00526045
Last Updated: 2020-12-17
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
117 participants
INTERVENTIONAL
2007-07-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Escalation
AUY922 2 mg/m2
HER2 Positive
AUY922 2 mg/m2
ER+ breast cancer
AUY922 2 mg/m2
Interventions
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AUY922 2 mg/m2
Eligibility Criteria
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Inclusion Criteria
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.
2. All patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression.
3. All patients must have progressive disease before entering the study
4. Age ≥ 18 years.
5. World Health Organization (WHO) Performance Status of ≤ 2.
6. Life expectancy of ≥ 12 weeks.
7. Absolute Neutrophil Count (ANC) 1.5 x 109/L; hemoglobin (Hgb) 9 g/dl; platelets (plt) 100 x 109/L; potassium, calcium, magnesium and phosphorus within normal limits or correctable with supplements; AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present; serum bilirubin 1.5 x ULN; serum albumin \> 2.5g/dl and serum creatinine 1.5 x ULN or 24-hour clearance 50 ml/min
Exclusion Criteria
* 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
* Trastuzumab treatment within 4 weeks
* Nitrosoureas, mitomycin and monoclonal antibodies (except trastuzumab): within 6 weeks
* Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday- Wednesday-Friday dosing, weekly etc) of systemic anticancer treatment for which the recovery period is not known, or investigational drugs (i.e. targeted agents) within a duration of ≤ 5 half lives of the agent and their active metabolites (if any)
4. Patients who have not recovered from side effects of previous systemic anticancer therapy to less than grade 2 CTCAE prior to the first dose.
5. Pregnant or lactating women.
* History (or family history) of long QT syndrome.
* Mean QTc ≥ 450 msec on screening ECG
* History of clinically manifest ischemic heart disease including myocardial infarction, stable or unstable angina, coronary arteriography or cardiac stress testing/imaging with findings consistent with coronary occlusion or infarction, ≤ 6 months prior to study start.
* History of heart failure or left ventricular (LV) dysfunction (LVEF ≤ 45%) by MUGA or ECHO
7. Known diagnosis of HIV infection (HIV testing is not mandatory).
8. Acute or chronic liver disease, acute or chronic renal disease or other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
Mean QTc ≥ 450 msec on screening ECG and clinically significant ECG abnormalities including one or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevations or depressions \> 1mm, or 2nd (Mobitz II) or 3rd degree AV block; clinically significant ECG abnormalities including one or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevations or depressions \> 1mm, or 2nd (Mobitz II) or 3rd degree AV block.
History (or family history) of long QT syndrome, heart failure or left ventricular (LV) dysfunction (LVEF ≤ 45%) by MUGA or ECHO, history of clinically manifest ischemic heart disease including myocardial infarction, stable or unstable angina, coronary arteriography or cardiac stress testing/imaging with findings consistent with coronary occlusion or infarction, ≤ 6 months prior to study start; history or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.
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
Locations
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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
Countries
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Related Links
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Resutls for CAUY922A2101 on the Novartis clinical trials website
Other Identifiers
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2006-002766-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAUY922A2101
Identifier Type: -
Identifier Source: org_study_id