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Metastatic Gastric CancerPhase 2HDACNCT01528501

Histone Deacetylases - Gastric Cancer (HDAC-GaCa-2008)

A Phase 2 study testing Panobinostat (LBH589) in people with Metastatic Gastric Cancer, run by Technical University of Munich at 2 sites in Germany.

Terminated

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

Official record
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Trial summary

This is an open-label, phase II trial evaluating the antitumor activity and safety of the oral Histone Deacetylase (HDAC)-Inhibitor LBH589. The treatment consists of 20 mg LBH589 three times a week in patients with chemo-refractory HDAC overexpressing. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Metastatic Gastric Cancer
What is being tested?
Panobinostat (LBH589)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesGermany
Study dates
Jun 2009to Feb 2013
Phase
Phase 2
Are there results?
None posted in the registry

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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients aged 18 - 90 years
  • Signed and dated informed consent of the patient before the start of specific protocol procedures
  • Histologically proven adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett carcinoma)
  • Measurable metastatic disease according to the RECIST (33). If locally recurrent disease, it must be associated with at least one measurable lymph node (> 20 mm by CT scan or > 10 mm with spiral CT)
  • Overexpression of at least one class I HDAC in the cancer biopsy as assessed by immunohistochemistry
  • Failure of prior palliative chemotherapy/chemotherapies (at least one Irinotecan- or Cisplatin-based). Failure is defined either by progression of disease or by significant toxicity that precludes further treatment
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  • At least 4 weeks from previous chemotherapy at first dose of trial drug
  • Resolution of all acute toxic side effects of prior therapy or surgical procedures to grade ≤ 1 NCI-CTC (except for the laboratory values)
  • Adequate organ function as defined by the following criteria:
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
  • Total serum bilirubin ≤ 1.5 x ULN
  • Absolute neutrophil count (ANC) ≥ 1500/µL
  • Platelets ≥ 100,000/µL
  • Hemoglobin ≥ 8.0 g/dL without support of growth factors (previous administration of erythrocyte concentrate is allowed)
  • Calculated CrCl ≥ 50 mL/min (MDRD Formula)
  • Serum calcium ≤ 12.0 mg/dL
  • Serum creatinine ≤ 2.0 x ULN
  • Lipase/Amylase ≤ 2,5 x ULN
  • All other laboratory values specified in chapter 7.5: resolution of all side effects of prior therapy or surgical procedure to grade < 3 NCI CTC
  • At least 4 weeks from any major surgery (at first dose of trial drug)
  • Karnofsky Performance Status (KPS) > 70
  • Life expectancy > 12 weeks
  • Patients must be able to swallow LBH589 capsules
  • Patients who understand the nature of the trial and are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
  • Female patients who are capable of bearing children must have a negative pregnancy test result (serum or urine) at trial entry. All women included in the trial must be surgically sterile or postmenopausal or agree to employ adequate birth control measures for the duration of the trial and six months post-dosing. Male patients must be surgically sterile or must agree to use effective contraception during the trial and six months post-dosing

Who cannot join

  • Other tumor type than adenocarcinoma (e.g., leiomyosarcoma, lymphoma) or a second cancer except in patients with squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix which has been effectively treated. Patients curatively treated and disease free for at least 5 years will be discussed with the sponsor before inclusion
  • Patients with known brain or leptomeningeal metastasis
  • Intake of non-permitted concomitant drugs (the coordinating investigator should be contacted to discuss the individual case), see chapter 5.4:
  • Concomitant treatment with antiarrhythmics and drugs with dysrhythmic potential (ie, terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide)
  • Prior exposure to a HDAC inhibitor compound
  • Administration of potent CYP34A inhibitors during or within 7 days before start of LBH589-treatment (e.g. ketoconazole, itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, indinavir, saquinavir, ritonavir, atazanavir, nelfinavir, grapefruit juice)
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  • Administration of potent CYP3A4 inducers during or within 12 days before start of LBH589-treatment (e.g. dexamethasone, rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John´s wort, efavirenz, tipranavir)
  • Ongoing treatment with therapeutic doses of anticoagulants such as Coumadin or heparins (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed)
  • Any other medicinal anticancer therapy during treatment phase except treatment with non-conventional therapies (e.g. herbs or acupuncture) and vitamins/mineral supplements, provided that they do not interfere with the trial endpoint, in the opinion of the investigator
  • Concurrent systemic immune therapy, chemo- or hormone therapy
  • Concomitant or within a 4-week period administration (from first dose of trial drug) of any other experimental drug under investigation) and participation in another clinical trial
  • Any prior radiotherapy of target lesions
  • Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis
  • Current history of chronic diarrhea and/or diarrhea > CTCAE grade 3
  • Active disseminated intravascular coagulation, or patients prone to thromboembolism
  • Known human immunodeficiency virus (HIV) infection
  • Active uncontrolled infection
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with trial participation or trial drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial
  • Known allergic/hypersensitivity reaction to any of the components of the treatment; or known drug abuse/alcohol abuse
  • Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
  • Known history of QT interval prolongation, ongoing QT prolongation (> 450 msec for males or > 470 msec for females), any cardiac ventricular dysrhythmias, atrial fibrillation of any grade
  • History or presence of sustained ventricular tachyarrhythmia. (Patients with a history of atrial arrhythmia are eligible but should be discussed with the Sponsor prior to enrollment)
  • Any history of ventricular fibrillation or torsade de pointes
  • Bradycardia defined as HR < 50 bpm. Patients with pacemakers are eligible if HR ≥ 50 bpm.
  • Screening ECG with a QTc > 450 msec
  • Right bundle branch block + left anterior hemiblock (bifascicular block)
  • Patients with myocardial infarction or unstable angina ≤ 6 months prior to starting study drug
  • Other clinically significant heart disease (e.g., CHF NY Heart Association class III or IV , uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
  • Patients who have received steroids (e.g. dexamethasone) ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy. Concomitant therapy medications that include corticosteroids are allowed if patients receive < 10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as pre-medication for administration of certain medications or blood products while enrolled in this study.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Klinikum rechts der Isar

    Munich, Bavaria, 81675

Other trials in Germany

About this study

Official title: An Open-label, Uncontrolled Phase II Trial of HDAC-Inhibitor LBH589 in Patients With Chemo-refractory Metastatic Gastric Cancer Overexpressing Histone Deacetylases (HDACs) - CLBH589BDE03T

This is an open-label, phase II trial evaluating the antitumor activity and safety of the oral Histone Deacetylase (HDAC)-Inhibitor LBH589. The treatment consists of 20 mg LBH589 three times a week in patients with chemo-refractory HDAC overexpressing.

metastatic adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett carcinoma). One cycle lasts 21 days. A total of 28 patients will be enrolled in this trial. In patients experiencing LBH589-related toxicity requiring treatment rest or dose reduction dose may be reduced. Subsequent dose adjustment will be permitted based on outcome. Treatment will continue until disease progression or intolerable adverse events. Subsequently, the patients will be followed-up for one year.

Being tested
Panobinostat (LBH589)
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Panobinostat (LBH589)Drug

Study groups in NCT01528501
Study groupRoleWhat they receive
IExperimentalNot described
Receives: Drug: Panobinostat (LBH589)

What is being measured

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

  1. objective response rate within the first six treatment cycles

    objective response rate (CR + PR) within the first six treatment cycles

Secondary outcomes (4)

  1. Progression free survival (PFS)

  2. 1-year survival

  3. Overall survival

  4. Safety and tolerability of LBH 589

    Analysis of adverse events and laboratory data

Timeline

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

  1. First posted8 Feb 2012 (estimated)
  2. Study startJun 2009
  3. Primary completionFeb 2013

Why it stopped: medical/ethical reasons

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
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528501
Sponsor's protocol ID
CLBH589BDE03T
Acronym
HDAC
Status last verified
Dec 2012
First submitted
1 Feb 2012
Last updated
1 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panobinostat (LBH589) in people with Metastatic Gastric Cancer, run by Technical University of Munich at 2 sites in Germany.

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 25 inclusion and 29 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 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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?

The study was stopped early (reason given: medical/ethical reasons). Results are not available in the source record.

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?

objective response rate within the first six treatment cycles. 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 NCT01528501.

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 1 May 2013.

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