Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer (Theragene)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02894944
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
NewGenPharm Inc.
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE September 9, 2016
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2016)
Number of participants with treatment-related adverse events assessed by CTCAE v4.03 [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02894944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2016)
  • Number of participants with treatment-related adverse events assessed by CTCAE v4.03 [ Time Frame: 12 weeks ]
  • Tumor response [ Time Frame: 8 weeks ]
  • Time to disease progression [ Time Frame: 6.5 months ]
  • Detection of Infected Adenovirus in blood and urine assessed by PCR [ Time Frame: 8 weeks ]
  • Detection of adenoviral DNA in blood by PCR [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
Official Title  ICMJE Clinical Trial Phase I for Evaluation of Tolerability and Safety of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
Brief Summary

Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival probability of less than 5% when all stages are combined. At present, only approximately 10%-20% of patients are considered candidates for curative resection. The majority of patients (50%-60%) are present with metastatic disease, and substantial number of patients (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.

Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic cancer in phase I study. From the experience of prostatic cancer, the safety of combination with standard chemotherapy with Theragene treatment is assessed in this study.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP
Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
Study Arms  ICMJE Experimental: Theragene arm
Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy
Intervention: Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2016)
9
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with pancreatic cancer stage 3
  • Patients with histologically confirmed pancreatic adenocarcinoma
  • Patients with no evidence of peritoneal or hematogenous metastasis
  • Patients with ECOG performance status 0-2
  • Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²)
  • Patients with bone marrow function (WBC > 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin > 10 g/dL)
  • Patients with liver function (Bilirubin < 2.0 mg/dL and SGOT and SGPT < 2.5 times upper limit of normal (ULN))
  • Patients with agreement with informed consent
  • Male patients with contraception

Exclusion Criteria:

  • Female patients with childbearing age or pregnancy or breast feeding
  • Patients with a history of chemotherapy within 5 years
  • Patients with a history of radiation on more than 25% of bone marrow
  • Patients with unknown stage or recurrent pancreatic cancer
  • Patients with a history of skin cancer except malignant melanoma or malignancy except stage 0 cervical cancer
  • Patients with a history of major surgery except laparoscopic exam, endoscopic ultrasound, stenting, or PEG/PEJ placement
  • Patients with active or uncontrolled infection
  • Patients with immunosuppression or susceptibility to viral infection
  • Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
  • Patients with a history of allergy to clinical trial medications
  • Patients who are considered as inappropriate candidate by investigators
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02894944
Other Study ID Numbers  ICMJE SNUBH-IMGPB-2016-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE NewGenPharm Inc.
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP