A PHASE III, RANDOMIZED, DOUBLE BLIND, CONTROLLED WITH PLACEBO TRIAL OF ORAL SUBEROILANILIDE HYDROXAMIC ACID (VORINOSTAT, MK 0683), IN PATIENTS WITH ADVANCED MALIGNO PLEURAL MESOTELIOMA, PRE-THERMOTALLY TREATED.
- Conditions
- -C450 Mesothelioma of pleuraMesothelioma of pleuraC450
- Registration Number
- PER-087-09
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Patients diagnosed with malignant pleural mesothelioma of epithelial, sarcomatoid or mixed histology, confirmed by histology and / or cytology
• The patient may not have received more than two previous systemic therapy regimens.
• Patients with an area of pleural cortex thickness of at least 1.0 cm in linear length, determined using the meso-RECIST criteria and modified [10] on a helical computed tomography (CT) scan.
• Patients 18 years of age or older.
• Patients with a score> 70 on the Karnofsky functional status scale
• Patients with adequate bone marrow function who do not use colony stimulating factors today
• Patients with adequate coagulation
• Patients with adequate liver function
• Patients with adequate renal function
• Patients must have completed previous chemotherapy or radiotherapy at least 4 weeks before drug administration (6 weeks in the case of nitrosoureas or mitomycin C) and must have recovered from any toxicity related to treatment (grade <1 according to Common terminology criteria for adverse events [CTCAE] of the National Cancer Institute [NCI] or having recovered levels prior to treatment).
• Women should be postmenopausal, be sterilized by surgical methods, be willing to use 2 adequate barrier contraceptive methods to prevent pregnancy or agree to abstain from heterosexual sexual activity during the study, from visit 1 and for at least 30 days after the last dose of the study drug. Males should agree to use an appropriate contraceptive method during the study.
• Patients who are willing to meet the requirements of the study and who are able to do so, including blood sampling, tumor evaluations and administration of the study drug.
• Patients who are able to understand and are willing to sign the informed consent approved by the ethical clinical research committee (CEIC).
• Patients who have received prior treatment with an HDAC inhibitor (eg, depsipeptide, MS-275, LAQ-824, PXD-101 and valproic acid). Patients who have received such drugs for other indications, for example, epilepsy, may participate in vorinostat trials after a 30-day pharmacological rest period.
• Patients with active infection for whom they have received antibiotics, antiviral or antifungal intravenously in the two weeks prior to the start of the study drug.
• Patients with a second currently active malignant neoplasm other than skin cancer other than melanoma and cervical carcinoma in situ will be excluded. It will be considered that the patient does not have a second malignancy currently active if he has completed the treatment for the second malignant tumor and has not presented the previous malignant disease in the last> 5 years.
• Patients with uncontrolled brain metastases, for example, previously treated brain metastases that have not stabilized in the last 6 weeks.
• Patients with a known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
• Pregnant or nursing patients.
• Patients with a known allergy to any of the components of the study drug.
• Patients with a history of gastrointestinal surgery or other procedures that may, in the opinion of the investigator, interfere with the absorption or swallowing of the study drug.
• Patients with poorly controlled intercurrent diseases or circumstances that may limit study compliance, for example (but not limited to): active infection, acute or chronic graft versus host disease, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia heart or psychiatric diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:It will be calculated between the moment of randomization and the moment of death. Patients who do not die during the study will be censored from the analysis at the time of the final visit.<br>Measure:Overall Survival<br>Timepoints:During the study<br>
- Secondary Outcome Measures
Name Time Method