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A Multi-Center, Open-Label, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Pancreas, Adenocarcinoma

Thank you

Trial Information

A Multi-Center, Open-Label, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma

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. This is a Targeted Cancer Therapy; DT-A chain expression is triggered by
the presence of H19 transcription factors that are only up-regulated in tumor cells. The
selective initiation of toxin expression results in selective tumor cell destruction via
inhibition of protein synthesis selectively in the tumor cell, enabling highly targeted
cancer treatment.

Inclusion Criteria:

1. Males or females > 18 years of age

2. If female, must not be pregnant or nursing; women of child-bearing potential must
practice a medically approved method of contraception

3. If male, must practice a medically approved method of contraception if have a partner
of childbearing potential

4. Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas

5. Locally advanced pancreatic cancer (LAPC) that is clinically unresectable as defined
in the NCCN Guidelines

6. Karnofsky performance status (KPS) ≥ 70% at baseline

7. 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)

8. 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

9. 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.

10. No prior diagnosis of malignancy within 3 years except for curatively treated
non-melanoma skin or in situ malignancies

11. Able to comply with the protocol procedures

12. Able and willing to provide written (signed) Informed Consent to participate in the

Exclusion Criteria:

1. 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

2. 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.

3. Known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or hepatitis B
virus (HBV) infection

4. Have clinically significant pancreatitis within 12 weeks of treatment

5. Have a clinical history of significant coagulopathy

6. 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

7. Have participated in any experimental therapeutic research study with an unapproved
drug within 4 weeks of the screening visit

8. Patients who require ongoing anticoagulation for pre-existing conditions, e.g.,
thrombophlebitis, pulmonary embolus or atrial fibrillation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival.

Outcome Time Frame:

an average of 16 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

September 2015

Related Keywords:

  • Pancreas, Adenocarcinoma
  • Pancreatic cancer
  • Gemcitabine
  • BC-819
  • Adenocarcinoma
  • Resectable
  • H19 gene
  • DTA-H19
  • BioCancell
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Winthrop University Hospital Mineola, New York  11501
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
Joe Arrington Cancer Research & Treatment Center Lubbock, Texas  79410