Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy

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Brief Title

Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy

Official Title

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

Brief Summary

      Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore
      may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies
      have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that
      lead to inhibition of tumor angiogenesis (a fundamental step in the transition of tumors from
      a dormant state to a malignant one). Bortezomib triggers cell death in pancreatic cancer
      cells but the mechanism is not well defined but has been determined to be cytostatic.
      Combining these two drugs may work together in the treatment of pancreatic cancer.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-Free Survival

Secondary Outcome

 Number of Participants by Tumor Response

Condition

Pancreatic Cancer

Intervention

Bortezomib

Study Arms / Comparison Groups

 Pancreatic Cancer Patients
Description:  Pancreatic cancer patients who received treatment with bortezomib and panobinostat after progressing on gemcitabine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

7

Start Date

September 2010

Completion Date

February 2011

Primary Completion Date

February 2011

Eligibility Criteria

        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
             enrollment:

               -  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
                  enrolled

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Arkadiusz Dudek, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01056601

Organization ID

2009LSUC012

Secondary IDs

X05302

Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

Arkadiusz Dudek, MD, Principal Investigator, Masonic Cancer Center, University of Minnesota


Verification Date

November 2017