Status:
TERMINATED
Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma
Lead Sponsor:
Anchiano Therapeutics Israel Ltd.
Conditions:
Pancreas, Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following intratumoral administr...
Detailed Description
BC-819 (also known as DTA-H19) is a double-stranded DNA plasmid, 4,560 base pairs (bp) in length, carrying the gene for the Diphtheria toxin A (DT-A) chain under the regulation of the H19 promoter. Th...
Eligibility Criteria
Inclusion
- Males or females \> 18 years of age
- If female, must not be pregnant or nursing; women of child-bearing potential must practice a medically approved method of contraception
- If male, must practice a medically approved method of contraception if have a partner of childbearing potential
- Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
- Locally advanced pancreatic cancer (LAPC) that is clinically unresectable as defined in the NCCN Guidelines
- Karnofsky performance status (KPS) ≥ 70% at baseline
- Adequate hematological, renal, and hepatic function
- Platelet count ≥ 100,000/mm3
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Hemoglobin ≥ 10.0 g/dL (may be achieved by transfusion)
- Creatinine (≤ 1.5 x ULN)
- ALT, AST (≤ 1.5 x ULN)
- Total Bilirubin (≤ 1.5 x ULN)
- Have a target tumor lesion in the pancreas ≤ 6 cm in diameter that is accessible for intratumoral administration by EUS guidance as determined by the physician performing the EUS injection
- Have a biopsy specimen that is positive for H19 expression (grade 2 or greater staining determined by a pathologist). H19 expression can be determined based on a biopsy specimen collected before study participation, if available.
- No prior diagnosis of malignancy within 3 years except for curatively treated non-melanoma skin or in situ malignancies
- Able to comply with the protocol procedures
- Able and willing to provide written (signed) Informed Consent to participate in the study
Exclusion
- Have distant metastatic spread (such as liver or lung metastases), peritoneal spread or malignant ascites. Regional lymph node involvement may be considered in accordance with the PI's judgment
- Received any prior therapy for the treatment of pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, other than up to4 single doses of gemcitabine chemotherapy.Patients who received prior gemcitabine will only be eligible, if they enter the study without evidence of disease progression.
- Known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or hepatitis B virus (HBV) infection
- Have clinically significant pancreatitis within 12 weeks of treatment
- Have a clinical history of significant coagulopathy
- Have a medical condition contraindicated for endoscopic-guided delivery and/or for IV administration of Gemcitabine or any intercurrent medical illness or other medical condition that would in the judgment of the investigator compromise patient safety or the objectives of the study
- Have participated in any experimental therapeutic research study with an unapproved drug within 4 weeks of the screening visit
- Patients who require ongoing anticoagulation for pre-existing conditions, e.g., thrombophlebitis, pulmonary embolus or atrial fibrillation
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01413087
Start Date
September 1 2011
End Date
May 1 2014
Last Update
November 1 2019
Active Locations (9)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
3
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas, United States, 79410
4
Carmel Medical Center
Haifa, Israel