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A phase 1 dose escalation, single center, open-label study of AUY922 administered IV on a once - weekly schedule in adult patients 75 years of age or older with advanced solid malignancies.
- The primary objective is to determine the maximally tolerated dose (MTD) of AUY922 as a single agent when administered iv on a once-weekly schedule to adult patients 75 years of age or older with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists.
- To characterize the safety and tolerability of treatment with AUY922
- To characterize the pharmacokinetic profiles of AUY922, including the parent drug and any potential metabolites.
- To determine the efficacy of AUY922 in elderly patients with measurable disease
- To evaluate of effect of geriatric-focused assessment of comorbidity and functional status on the toxicity and response to AUY922
- Patients must have a histologically proven solid tumor malignancy which is refractory to standard therapy and for which no curative therapy is available
- Patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression
- Age ≥ 75 years
- ECOG Performance Status of ≤ 1
- Life expectancy of ≥ 12 weeks
- Patients must have the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5x10^9/L
- Hemoglobin (Hgb) ≥ 9 g/dl
- Platelets (plt) ≥ 100x10^9/L
- Potassium within normal limits or correctable with supplements
- Total calcium (corrected for serum albumin) and phosphorus within normal limits
- Magnesium above LLN or correctable with supplements
- Liver and Kidney Functions
- AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) if no liver metastases are present
- AST/SGOT and ALT/SGPT ≤ 5 x ULN if liver metastases are present
- Serum bilirubin ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 ml/min
- Patients must be able to understand and voluntarily sign written informed consent
- Male participants with partners who are of child bearing potential must 1. Agree to use double barrier method of birth control 28 days prior to study entry, during course of study and for 28 days following the last dose of AUY922 OR 2. Have history of a vasectomy.
- Patients with CNS metastasis which are:
- Symptomatic or
- Require treatment for symptom control and/or
- Note: Patients without clinical signs or symptoms of CNS involvement are not required to have a CT/MRI of the brain
- Prior treatment with any HSP90 or HDAC inhibitor compounds
- Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
- Radiotherapy or conventional chemotherapy: within 4 weeks
- Palliative radiotherapy: within 2 weeks
- Nitrosoureas, mitomycin, or monoclonal antibodies, such as trastuzumab, within 6 weeks
- Any systemic anti-cancer treatment for which the elimination 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)
- Treatment with therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2 mg, for line patency permitted]
- Unresolved diarrhea ≥ CTCAE grade 1, despite treatment with antidiarrheal agents
- Patients with malignant ascites that require invasive treatment
- Male patients whose partners are WCBP not using double-barrier methods of contraception.
- Acute or chronic liver or renal disease
- Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.
- Major surgery ≤ 2 weeks prior to Cycle 1, Day 1 or who have not recovered from such therapy. (Placement of a venous access device within 2 weeks is permitted)
- Impaired cardiac function, including any one of the following:
- History (or family history) of long QT syndrome
- Mean QTc ≥ 450 msec on baseline ECG
- History of clinically manifested ischemic heart disease ≤ 6 months prior to study start
- History of heart failure or left ventricular (LV) dysfunction (LVEF ≤ 45%) by MUGA or ECHO
- Clinically significant ECG abnormalities including 1 or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevation or depression > 1mm, or 2nd (Mobitz II), or 3rd degree AV block.
- History or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes
- Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- Clinically significant resting bradycardia (< 50 beats per minute)
- Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTcB interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922. A list of drugs that may cause QT prolongation or Torsades de Pointes is shown in Appendix 1.
- Patients who are dependent on a pacemaker due to cardiac conduction dysfunctionKnown diagnosis of HIV infection (HIV testing is not mandatory)
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Patients unwilling or unable to comply with the protocol
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