An open-label, uncontrolled phase II trial of HDAC inhibitor LBH589 in patients with chemo-refractory metastatic gastric cancer overexpressing histone deacetylases - CLBH589BDE03T - HDAC-GaCa-2008
- Conditions
- A study with patients with chemo-refractory metastatic gastric cancer overexpressing histone deacetylases (HDACs)
- Registration Number
- EUCTR2008-002721-37-DE
- Lead Sponsor
- Medizinische Fakultät der TU-München, vertreten durch den Dekan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
- Histologically proven adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett carcinoma)
- Measurable metastatic disease according to the RECIST (33).
- Overexpression of at least one class I HDAC in the cancer biopsy as assessed by immunohistochemistry.
- Failure of prior palliative chemotherapy/chemotherapies
- 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
- Adequate organ function as defined by the following criteria
- At least 4 weeks from any major surgery (at first dose of trial drug)
- Karnofsky Performance Status (KPS) > 70
- Life expectancy > 12 weeks
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 in the protocol:
- 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
- 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 (see protocol)
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to evaluate the antitumor activity of HDAC Inhibitor LBH589 administered as a single agent in patients with metastatic gastric cancer overexpressing HDACs refractory to cisplatin- and/or irinotecan-based chemotherapy;Secondary Objective: The secondary objectives are:<br>1. Effects of HDAC-Inhibitor LBH589 on the time to tumor progression (PFS)<br>2. Effects of HDAC-Inhibitor LBH589 on survival (one-year survival and overall survival) <br>3. Safety and tolerability of HDAC-Inhibitor LBH589 <br>;Primary end point(s): The primary endpoint is the objective response rate (CR + PR) within the first six treatment cycles <br>
- Secondary Outcome Measures
Name Time Method