Pancreatic CancerPhase 1TherageneNCT02894944
Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
A Phase 1 study testing Theragene®,Ad5-yCD/mutTKSR39rep-ADP in people with Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Theragene®,Ad5-yCD/mutTKSR39rep-ADP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Theragene®,Ad5-yCD/mutTKSR39rep-ADP
- Keywords
- Pancreatic cancer, Adenovirus, Gene therapy
- Medical subject headings
- Pancreatic Neoplasms, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theragene®,Ad5-yCD/mutTKSR39rep-ADPBiological
Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
| Study group | Role | What they receive |
|---|---|---|
| Theragene arm | Experimental | Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy Receives: Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events assessed by CTCAE v4.03
Measured: 8 weeks
Secondary outcomes (5)
Number of participants with treatment-related adverse events assessed by CTCAE v4.03
Measured: 12 weeks
Tumor response
Measured: 8 weeks
Time to disease progression
Measured: 6.5 months
Detection of Infected Adenovirus in blood and urine assessed by PCR
Measured: 8 weeks
Detection of adenoviral DNA in blood by PCR
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NewGenPharm Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894944
- Sponsor's protocol ID
- SNUBH-IMGPB-2016-02
- Acronym
- Theragene
- Status last verified
- Aug 2019
- First submitted
- 10 Aug 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee JC, Shin DW, Park H, Kim J, Youn Y, Kim JH, Kim J, Hwang JH. Tolerability and safety of EUS-injected adenovirus-mediated double-suicide gene therapy with chemotherapy in locally advanced pancreatic cancer: a phase 1 trial. Gastrointest Endosc. 2020 Nov;92(5):1044-1052.e1. doi: 10.1016/j.gie.2020.02.012. Epub 2020 Feb 19.
PubMed 32084409
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02894944
- Acronym / sponsor ID
- Theragene / SNUBH-IMGPB-2016-02
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Adenovirus, Gene therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- NewGenPharm Inc.
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theragene arm | Experimental | Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADPPatients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theragene®,Ad5-yCD/mutTKSR39rep-ADPTheragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy | Biological | Theragene arm |
Primary outcome
Number of participants with treatment-related adverse events assessed by CTCAE v4.03
Time frame: 8 weeks
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Derived from this study: PubMed 32084409Lee JC, Shin DW, Park H, Kim J, Youn Y, Kim JH, Kim J, Hwang JH. Tolerability and safety of EUS-injected adenovirus-mediated double-suicide gene therapy with chemotherapy in locally advanced pancreatic cancer: a phase 1 trial. Gastrointest Endosc. 2020 Nov;92(5):1044-1052.e1. doi: 10.1016/j.gie.2020.02.012. Epub 2020 Feb 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Theragene®,Ad5-yCD/mutTKSR39rep-ADP in people with Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events assessed by CTCAE v4.03 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02894944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.