A Study of the HSP90 Inhibitor AUY922

Stopped early · Phase 2

Conditions studied: Lymphoma

In brief

The goal of this clinical research study is to learn if AUY922 can help to control refractory or recurrent lymphoma. The safety of AUY922 will also be studied. AUY922 is designed to block tumor growth by blocking a protein.

Key facts

Study ID

NCT01485536

Run by

M.D. Anderson Cancer Center

People needed

21

Starts

2012-08-01

Expected to finish

2015-11-01

Last updated by the study team

2017-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/= 18 years
• Able to sign Informed Consent
• Patients must have the following laboratory values: Hematologic: Absolute Neutrophil Count (ANC) >/=1.5x10\^9/L; Hemoglobin (Hgb) >/=9 g/dl; Platelets (plt) >/=50 x10\^9/L. Biochemistry: Potassium within normal limits; Total calcium (corrected for serum albumin) and Phosphorus within normal limits o Magnesium above LLN or correctable with supplements; Liver and Kidney Functions: aspartate aminotransferase (AST)/serum glutamate oxaloacetate transaminase (SGOT) and ALT/serum glutamate pyruvate transaminase (SGPT) </=1.5 x Upper Limit of Normal (ULN) if Alkaline Phosphate (AP) > 2.5 ULN AST/SGOT and ALT/SGPT </=2.5 x Upper Limit of Normal (ULN) if Alkaline Phosphate (AP) </=5.0 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.
• Negative serum pregnancy test. The serum pregnancy test must be obtained prior to the first administration of AUY922 (</= 72 hours prior to dosing) in all pre-menopausal women and women <2 years after the onset of menopause
• Histologically confirmed Diffuse Large B-cell Lymphoma (DLBCL), (primary mediastinal DLBCL, DLBCL-NOS, large B-cell transformation of indolent B-cell lymphoma including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma) or Peripheral T-cell Lymphoma (PTCL), including PTCL not otherwise specified, angioimmunoblastic lymphoma, anaplastic large T-cell lymphoma, hepatosplenic T-cell lymphoma, enteropathy associated T-cell lymphoma; nodal or extranodal NK/T-cell lymphoma, mycosis fungoides with radiographically measurable disease.
• Relapsed or refractory after standard treatments and with no curative option with conventional therapy.
• Measurable disease.
• No known evidence of cerebral or meningeal involvement by lymphoma.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

You may not qualify if…

• Diarrhea > CTCAE (v4.02) grade 1 that cannot be controlled with oral anti-diarrhea medications.
• Pregnant or lactating women.
• Fertile women of childbearing potential (WCBP), a female that has not been surgically sterilized or that has not been amenorrheic for at least 24 consecutive months, not using double-barrier methods of contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile). Male patients whose partners are WCBP not using double-barrier methods of contraception.
• 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 multigated radionuclide angiography (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.
• Continuation #4) 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 (2 consecutive reading >140/90), 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 QTcF interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922;
• Obligate use of a cardiac pacemaker.
• All lymphomas except for Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL).
• Chemotherapy or radiation therapy or other investigational agents within 3 weeks prior to entering the study.
• Previous radioimmunotherapy within 12 weeks.
• Patient with known HIV infection.
• Known active viral hepatitis.
• Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study.
• Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives in the opinion of the investigator.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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