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A Phase II Trial of Panobinostat in Patients With Neuroendocrine Tumors

Phase 2
18 Years
Not Enrolling
Neuroendocrine Tumors

Thank you

Trial Information

A Phase II Trial of Panobinostat in Patients With Neuroendocrine Tumors

Inclusion Criteria:

- Histologically confirmed, metastatic, low grade neuroendocrine neoplasms. Small cell
lung cancers, paragangliomas, and pheochromocytomas are excluded

- Must have measurable disease as defined by RECIST

- 4 weeks from completion of major surgery, chemotherapy, or other systemic therapy or
local liver therapy to study registration. Concurrent octreotide is allowed.

- Not allowed to be on concurrent chemotherapy or radiation

- 18 years of age or older

- ECOG Performance status of equal to or less than 2

- Able to sign and date a written informed consent prior to participation in the study

- Baseline MUGA or ECHO must demonstrate LVEF greater than or equal to the lower limit
of the institutional normal

- Must have the following laboratory criteria: Neutrophil count greater than 1500/mm3,
platelet count greater than 100,000/mm3L, hemoglobin greater than or equal to 9 g/dL,
AST/SGOT and ALT/SGPT less than or equal to 2.5 x ULN, serum bilirubin less than or
equal to 1.5 x ULN, serum creatinine less than or equal to 1.5 x ULN, total serum
calcium greater than or equal to LLN, serum potassium greater than or equal to LLN,
serum sodium greater than or equal to LLN, serum albumin greater than or equal to LLN
or 3g/dl,

- Women of child bearing potential must have a negative urine pregnancy test within 72
hours of first administration of study treatment and must be willing to use two
methods of contraception

- Patients with a history of hypertension must be well controlled (to less than 150/90
mmHg) on a stable regimen of anti-hypertensive therapy

Exclusion Criteria:

- Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer

- Patients who will need valproic acid for any medical condition during the study or
within 5 days prior to the first panobinostat treatment

- Impaired cardiac function including any of the following: Screening ECG with a QTc
greater than 450 msec, patients with congenital long QT syndrome, history of
unsustained ventricular tachycardia, any history of ventricular fibrillation or
torsades de pointes, bradycardia defined as heart rate less than 50 beats per
minutes, patients with a myocardial infarction or unstable angina within 6 months of
study entry, congestive heart failure, right bundle branch block or left anterior

- Uncontrolled hypertension

- Unresolved diarrhea greater than CTCAE grade 1

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral panobinostat

- Other concurrent sever and/or uncontrolled medical conditions

- Patients with a history of another primary malignancy that, in the opinion of the
investigator, would interfere with the assessment of the primary endpoint of the

- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C,
baseline testing is not required

- Any significant history of non-compliance to medical regimens or with inability to
grant a reliable informed consent

- Any medication which may cause QTc prolongation or inducing torsades de pointes

- Use of concomitant medications that may interact with panobinostat

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

This study will measure the tumor response rate of patients with gastrointestinal neuroendocrine tumors using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator

Noelle LoConte, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:

2010-0050 (CO08209)



Start Date:

May 2010

Completion Date:

December 2012

Related Keywords:

  • Neuroendocrine Tumors
  • Neuroendocrine Tumors



University of Wisconsin, Madison Madison, Wisconsin  53792