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Phase II Study of Panobinostat (LBH589) Given in Combination With Bortezomib (Velcade) in Patients With Pancreatic Cancer Progressing on Gemcitabine Therapy Alone or Gemcitabine in Combination

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

Phase II Study of Panobinostat (LBH589) Given in Combination With Bortezomib (Velcade) in Patients With Pancreatic Cancer Progressing on Gemcitabine Therapy Alone or Gemcitabine in Combination

Inclusion Criteria:

- Histological diagnosis of locally advanced or metastatic pancreatic cancer (except
neuroendocrine tumors, but including ampullary cancer) with progression after
standard first line therapy that included gemcitabine (single agent or combination)

- Measurable disease on computated tomography (CT) scan per Response Evaluation
Criteria in Solid Tumors (RECIST) criteria

- At least 28 days from previous systemic therapy, including investigational agents and
1st dose of study treatment and recovered from any acute toxic effects of that
treatment before study enrollment.

- Has Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 - Ability to
provide written consent

- Must meet hematology and biochemistry laboratory criteria within 14 days of study

- Neutrophil count >1500/mm^3

- Platelet count >100,000/mm^L

- Hemoglobin > or = 9 g/dL

- Aspartate aminotransferase (AST/SGOT) or Alanine transaminase (ALT/SGPT) < or =
2.5 times upper limit of normal (ULN)or ≤ 5.0 x ULN if the transaminase
elevation is due to disease involvement

- Serum bilirubin < or = 1.5 x ULN

- Serum creatinine < or = 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min

- Total serum calcium (corrected for serum albumin) or ionized calcium ≥ lower
limit of normal (LLN)

- Serum phosphorus > or = LLN

- Serum potassium > or = LLN

- Serum sodium ≥ LLN

- Serum magnesium ≥ LLN

- Serum albumin ≥ LLN or 3g/dl

- Patients with any elevated Alkaline Phosphatase due to bone metastasis can be

- Baseline multi gated acquisition scan (MUGA) or echocardiogram (ECHO) must
demonstration left ventricular ejection fraction (LVEF) > or = 50%

- Normal thyroid function within normal limits. Note: Patients are permitted to receive
thyroid hormone supplements to treat underlying hypothyroidism.

- Women of childbearing potential (WOCBP) must have a negative pregnancy tests within 7
days of study treatment administration and willing to use 2 methods of contraception

Exclusion Criteria:

- > 1 prior systemic treatment regimen for pancreatic cancer

- Prior histone deacetylase (HDAC), deacetylase (DAC), heat shock protein 90 (HSP90)
inhibitors or valproic acid for treatment of cancer

- Anyone needing valproic acid for any medical condition during the study or 5 days
prior to panobinostat treatment

- Impaired cardiac function

- Complete left bundle branch block or use of a permanent cardiac pacemaker,
congenital long QT syndrome, history or presence of ventricular
tachyarrhythmias, clinically significant resting bradycardia (<50 beats per
minute), QTcF > 450 msec on screening ECG, or right bundle branch block + left
anterior hemiblock (bifascicular block)

- Presence of atrial fibrillation (ventricular heart rate >100 bpm)

- Previous history angina pectoris or acute myocardial infarction (MI) within 6
months of study enrollment

- Congestive heart failure (New York Heart Association functional classification
III-IV) or baseline MUGA/Echo shows LVEF < 50%

- Uncontrolled hypertension defined as hypertensive blood pressure of SBP > 140 or DBP
> 90, despite antihypertensive medications

- History of deep vein thrombosis (DVT), pulmonary emboli or other blood clotting
abnormality within 3 months of study enrollment

- Ongoing need for anti-coagulation therapy except daily low dose aspirin (≤ 100
mg/day) or low molecular weight heparin

- Concomitant use of drugs with risk of causing torsades de pointes

- Anyone with unresolved diarrhea > or = grade 2 at time of enrollment

- Impairment of gastrointestinal function or disease that may significantly alter the
absorption of panobinostat

- Grade 2 or greater peripheral neuropathy within 14 days of enrollment

- Serious concomitant medical or psychiatric disorders (e.g., active infection,
uncontrolled diabetes)

- Patients who have received chemotherapy, any investigational agent or undergone major
surgery < 4 weeks prior to starting study drug

- Male patients whose sexual partners are WOCBP and not using double method of
contraception during the study and 3 months following.

- Known positivity for human immunodeficiency virus (HIV) or hepatitis C

- Hypersensitivity to bortezomib, boron or mannitol History of another primary
malignancy within 5 years other than curatively treated CIS of the cervix, or basal
or squamous cell carcinoma of the skin

Type of Study:


Study Design:

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

Outcome Measure:

Progression-Free Survival

Outcome Description:

Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.

Outcome Time Frame:

Up to 1 Year

Safety Issue:


Principal Investigator

Arkadiusz Dudek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

February 2011

Related Keywords:

  • Pancreatic Cancer
  • insulinoma
  • cancer of pancreas
  • neoplasms, pancreas
  • alpha-cell tumor
  • glucagonoma
  • beta-cell tumor
  • somatostatinoma
  • Pancreatic Neoplasms



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455