An Exploratory Trial to Evaluate Efficacy and Safety for... | NCT04739046

Studies
An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy

NCT04739046

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Mar 17, 2021Actual

Enrollment

12Estimated

Phase

Phase 2

Conditions

Pancreas Cancer

Interventions

Theragene arm

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Aug 1, 2022Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

Feb 1, 2021

First Submission Date that Met QC Criteria

Feb 1, 2021

First Posted Date

Feb 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2021

Last Update Posted Date

Mar 17, 2021Actual

Name	Class
NewGenPharm Incoporation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed safety and anti-cancer effect in patients with pancreatic cancer in phase I study.

From the experience of phase I study, the safety and efficacy of combination with standard chemotherapy and radiation therapy with Theragene treatment will be assessed in this study.

Detailed Description

Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Theragene arm	Experimental	Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy	Drug: Theragene arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Theragene arm	Drug	Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy	Theragene arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate	the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Disease control rate	the proportion of patients with advanced or metastatic cancer who have achieved complete response, partial response or stable disease	24 weeks
Tumor marker test	change of tumor marker in the process of assigned treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with borderline resectable or locally advanced pancreatic cancer
Patients with histologically confirmed pancreatic adenocarcinoma
Patients with no evidence of peritoneal or hematogenous metastasis
Patients with ECOG performance status 0-1
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 < 3 times upper limit of normal (ULN))
Patients with agreement with informed consent

Exclusion Criteria:

Patients with a history of other cancer
Patients with recurred pancreatic cancer
Patients with a history of radiation on more than 25% of bone marrow
Patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy
Patients who have contraindication of radiation therapy
Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
Female patients with childbearing age or pregnancy or breast feeding
Patients who are considered as inappropriate candidate by investigators

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin-Hyeok Hwang, MD PhD	Contact	+82-31-787-7017		wooltong@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Jin-Hyeok Hwang, MD PhD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D000257	Adenoviridae Infections

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

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Browse Branches

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