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Pancreatic CancerPhase 2NCT01056601

Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy

A Phase 2 study testing Bortezomib and Panobinostat in people with Pancreatic Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Bortezomib and Panobinostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
Sep 2010to Feb 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • > 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)
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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

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.

Being tested
Bortezomib, Panobinostat
Keywords
insulinoma, cancer of pancreas, neoplasms, pancreas, alpha-cell tumor, glucagonoma, beta-cell tumor, somatostatinoma
Medical subject headings
Pancreatic Neoplasms, Insulinoma, Glucagonoma, Somatostatinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

    Also called Velcade

    1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period

  • PanobinostatDrug

    Also called LBH589

    20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period

Study groups in NCT01056601
Study groupRoleWhat they receive
Pancreatic Cancer PatientsExperimentalPancreatic cancer patients who received treatment with bortezomib and panobinostat after progressing on gemcitabine.
Receives: Drug: Bortezomib; Drug: Panobinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival

    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.

    Measured: Up to 1 Year

Secondary outcomes (2)

  1. Number of Participants by Tumor Response

    Number of patients whose tumor has responded to study therapy is determined using Response Evaluation Criteria In Solid Tumors. Progressive Disease (PD) is assessed if the sum of the diameters has increased by ≥ 20% and ≥ 5 mm from nadir (including baseline if it is the smallest sum). Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.

    Measured: Up to 1 Year

  2. Duration of Response

    Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed Complete or Partial Response as defined by RECIST criteria).

    Measured: Up to 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Why it stopped: Funding not available

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01056601
Sponsor's protocol ID
2009LSUC012
Other IDs
X05302
Status last verified
Nov 2017
First submitted
25 Jan 2010
Last updated
28 Dec 2017
Data monitoring committee
Yes

Publications

  • Tost J, Ak-Aksoy S, Campa D, Corradi C, Farinella R, Ibanez-Costa A, Dubrot J, Earl J, Melian EB, Kataki A, Kolnikova G, Madjarov G, Chaushevska M, Strnadel J, Tanic M, Tomas M, Dubovan P, Urbanova M, Buocikova V, Smolkova B. Leveraging epigenetic alterations in pancreatic ductal adenocarcinoma for clinical applications. Semin Cancer Biol. 2025 Feb;109:101-124. doi: 10.1016/j.semcancer.2025.01.003. Epub 2025 Jan 23.

    PubMed 39863139

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib and Panobinostat in people with Pancreatic Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: Up to 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01056601, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.

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