NCT00826150

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Anchiano Therapeutics Israel Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BC-819	Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-01-21
• Last updated: 2019-06-13
• Results posted: 2019-06-13

Locations

4 sites across 1 country: Israel