Suberoylanilide Hydroxamic Acid (SAHA) Vs Placebo In Treating Advanced Malignant Pleural Mesothelioma
The Clinical trial -Suberoylanilide Hydroxamic Acid (SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma is both a Phase II as well as a Phase III treatment procedure. The trial is in the active stage with the Protocol ID 2005_010, MK0683-014 and NCT00128102.
This study is fundamentally a Phase III trial with a preliminary Phase II component to examine the tolerability, safety and anti- tumor effectiveness of suberoylanilide hydroxamic acid which is an investigational drug consumed orally during the treatment of malignant Pleural Mesothelioma in an advanced stage.
The trial has strict guidelines regarding the eligibility of the participants. The age of a participant must be at least 18 years to be eligible for this study. There should be confirmation regarding the detection of Pleural Mesothelioma. Those patients who did not get any favorable response from a previous Chemotherapy using cisplatin or carboplatin would meet the eligibility criteria. Proper functioning of the liver, bone marrow and kidney are extremely essential to get qualified for the trial. Ability to swallow pills and that of self care are also the other eligibility criteria. Patients who are absolutely bed ridden are also excluded.
But the patients who had already been treated by a similar investigational drug with like properties are excluded from this study. If an active infection had developed within 2 weeks of the application of the investigational drug or if the patient had been treated with an intravenous antibiotic or an antifungal medication within 2 weeks of the receipt of the drug then the patients would lose their eligibility to proceed further. Pregnant patients suffering from malignant Pleural Mesothelioma or those who are breast feeding their babies are also excluded from this trial.
Merck and Company, Incorporated is the sponsor of the trial and the various trial sites include Haar, Haarlem, Auckland, Madrid, Sollentuna and Hoddesdon. The Study Director of the pharmaceutical company happens to be the Medical Monitor and he can be contacted at the toll free number- 1-888-577-8839.