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

NCT00826150 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-06-13

Study results available
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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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Anchiano Therapeutics Israel Ltd.

    lead INDUSTRY

Principal Investigators

  • Tally Levy, M.D. · The Edith Wolfson Medical Center

  • David Edelman, MD · Hadassah University Hospital

  • Ami Fishman, MD · Meir Medical Center

  • Eitan Rami, MD. · Rabin Medical Center

  • Ofer Lavie, M.D. · Carmel Medical Center

  • Ronnie Shapira-Frommer, MD · Sheba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826150 on ClinicalTrials.gov