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Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer

NCT00711997 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-03-20

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 intratumorally in patients with unresectable, locally advanced pancreatic cancer.

Primary Objective: The primary objective is to determine the maximum tolerated dose (MTD) of intratumoral DTA-H19 and identify any dose limiting toxicities (DLTs).

Secondary objectives include determining the adverse events (AEs) profile, effects on clinical laboratory analytes, vital signs, PK, tumor response, and possible tumor resectability after 4 intratumoral administrations of DTA-H19.

Conditions

  • Pancreatic Neoplasms

Interventions

BIOLOGICAL

DTA-H19

Cohort #1: 4 mg DTA-H19 intratumorally 2 times per week for 2 weeks Cohort #2: 8 mg DTA-H19 intratumorally 2 times per week for 2 weeks

Sponsors & Collaborators

  • Anchiano Therapeutics Israel Ltd.

    lead INDUSTRY

Principal Investigators

  • Abraham Czerniak, MD · The Chaim Sheba Medical Center

  • Nader Hanna, MD, FACS · University of Maryland

  • Fred Konikoff, MD · Meir Medical Center

  • Ayala Hubert, MD · Hadassah University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • United States
  • Israel

Study Locations

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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 NCT00711997 on ClinicalTrials.gov