Spots Global Cancer Trial Database for Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer

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Trial Identification

Brief Title: Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer

Official Title: Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer

Study ID: NCT00826150

Conditions

Ovarian Cancer

Interventions

BC-819

Study Description

Brief Summary: This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer, or primary peritoneal carcinoma

Detailed Description: This is a Phase 1/2a, open label, dose escalation, repeat dose study in 11 subjects with recurrent, platinum resistant advanced stage ovarian cancer or primary peritoneal carcinoma designed to determine the tolerability, safety, quality of life, PK, and preliminary efficacy of DTA-H19 administered intraperitoneally(IP). Primary Objective: The primary objectives of this study are: * To determine the maximum tolerated dose (MTD) of IP DTA-H19; and, * To identify any dose limiting toxicities (DLTs). Secondary Objectives: Secondary objectives of this study are: * To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19; * To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary. * To determine the overall survival distribution.