Overview

A Study of the HSP90 Inhibitor AUY922

Status:
Terminated

Trial end date:
2015-11-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Novartis

Criteria

Inclusion Criteria:

1. Age >/= 18 years

2. Able to sign Informed Consent

3. 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)
2.5 ULN AST/SGOT and ALT/SGPT Phosphate (AP) ULN; Serum creatinine /= 50 ml/min.

4. Negative serum pregnancy test. The serum pregnancy test must be obtained prior to the
first administration of AUY922 ( women and women <2 years after the onset of menopause

5. 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.

6. Relapsed or refractory after standard treatments and with no curative option with
conventional therapy.

7. Measurable disease.

8. No known evidence of cerebral or meningeal involvement by lymphoma.

9. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

1. Diarrhea > CTCAE (v4.02) grade 1 that cannot be controlled with oral anti-diarrhea
medications.

2. Pregnant or lactating women.

3. 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.

4. 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 History of heart failure or left ventricular (LV) dysfunction (LVEF 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.

5. 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;

6. Obligate use of a cardiac pacemaker.

7. All lymphomas except for Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell
Lymphoma (PTCL).

8. Chemotherapy or radiation therapy or other investigational agents within 3 weeks prior
to entering the study.

9. Previous radioimmunotherapy within 12 weeks.

10. Patient with known HIV infection.

11. Known active viral hepatitis.

12. 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.

13. 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.