Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00711997|
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : December 2, 2013
Last Update Posted : December 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Biological: DTA-H19||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intratumoral Administration of DTA-H19 in Patients With Unresectable Pancreatic Cancer|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||December 2010|
Intratumoral administration of BC-819
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
Other Name: BC-819
- Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819 [ Time Frame: Week 4 ]Number of Participants Reaching Maximal Tolerated Dose (MTD)
- Tumor Response [ Time Frame: 4 weeks ]Tumor response and progression were defined in accordance with RECIST v. 1.0 and assessed by radiological examination 2 weeks after the end of treatment
- Tumor Resectability [ Time Frame: 5 to 6 weeks ]The number of subjects in each cohort whose tumor was resectable at the end of the study was to be presented for the ITT and the per-protocol population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711997
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201-1595|
|Hadassah University Hospital|
|Kfar Saba, Israel|
|The Chaim Sheba Medical Center|
|Tel Hashomer, Israel|
|Principal Investigator:||Abraham Czerniak, MD||The Chaim Sheba Medical Center|
|Principal Investigator:||Nader Hanna, MD, FACS||University of Maryland|
|Principal Investigator:||Fred Konikoff, MD||Meir Medical Center|
|Principal Investigator:||Ayala Hubert, MD||Hadassah University Hospital|