Phase II Study of PXD101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma
I. Determine the objective response rate in patients with unresectable malignant pleural
mesothelioma (MPM) treated with PXD101.
I. Determine the overall survival and time to progression in these patients. II. Assess the
toxicities associated with this drug in these patients. III. Perform molecular correlative
studies on tumor tissue (optional) and peripheral blood (required) and identify potential
predictive markers for response.
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection during course 1 of treatment for biomarker correlative
studies. Fetal hemoglobin (hemoglobin F) levels are measured via reverse
transcriptase-polymerase chain reaction as a potential predictive marker for response.
After completion of study treatment, patients are followed periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee
Up to 3 years
Beckman Research Institute
United States: Food and Drug Administration
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