Pancreatic Cancer Non-resectablePhase 1/2V3-PNCT03165591
Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer
A Phase 1/2 study testing V3-P in people with Pancreatic Cancer Non-resectable, run by Immunitor LLC at 2 sites in Mongolia.
Trial summary
Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- V3-P
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesMongolia
- Study dates
- 1 May 2017to 31 Dec 2020
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of inoperable pancreatic cancer
- higher than normal of serum CA19.9 tumor marker levels (40 IU/ml)
- must be able to swallow tablets
Who cannot join
- negative for CA19.9
- pregnant, breast feeding women
- unwillingness to provide written consent
Trial locations and contacts
2 sites in 1 country.
Mongolia2 sites, 2 recruiting
- Recruiting
Immunitor LLC
Ulaanbaatar
Aldar Bourinbaiar, MD, 97695130306, aldar@immunitor.com
Marina Tarakanovskaya, MD, marinatarakanovskaya@yahoo.com
- Enrolling by invitation
National Cancer Center
Ulaanbaatar
About this study
Official title: Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer
Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery.
We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.
Read the detailed description
This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- V3-P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V3-PBiological
Also called oral tableted therapeutic vaccine
one tablet of V3-P given once daily for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Daily tablet of V3-P given orally for 2 months Receives: Biological: V3-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of V3-P on tumor burden
Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-P in an open label trial in patients with inoperable pancreatic cancer.
Measured: 3 months
Secondary outcomes (2)
Safety of V3-P
Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE.
Measured: 3 months
Effect of V3-P on sugar and bilirubin levels
Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 May 2017
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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 Cancer Non-resectableStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunitor LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allen Bain, PhD, Study chair, Immunitor Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165591
- Sponsor's protocol ID
- Panc-001
- Acronym
- V3-P
- Status last verified
- Aug 2019
- First submitted
- 18 May 2017
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be shared with other researchers upon request on study conclusion
Publications
Tarakanovskaya MG, Chinburen J, Batchuluun P, Munkhzaya C, Purevsuren G, Dandii D, Hulan T, Oyungerel D, Kutsyna GA, Reid AA, Borisova V, Bain AI, Jirathitikal V, Bourinbaiar AS. Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L. J Hepatocell Carcinoma. 2017 Apr 12;4:59-69. doi: 10.2147/JHC.S122507. eCollection 2017.
PubMed 28443252
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03165591
- Acronym / sponsor ID
- V3-P / Panc-001
- Conditions
- Pancreatic Cancer Non-resectable
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Immunitor LLCIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 May 2017 (actual)
- 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 (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery.
We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.
Detailed description
This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: V3-PDaily tablet of V3-P given orally for 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of inoperable pancreatic cancer
- higher than normal of serum CA19.9 tumor marker levels (40 IU/ml)
- must be able to swallow tablets
Key exclusion criteria (3 listed)
- negative for CA19.9
- pregnant, breast feeding women
- unwillingness to provide written consent
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 |
|---|---|---|
| V3-PAlso: oral tableted therapeutic vaccineone tablet of V3-P given once daily for 2 months | Biological | Experimental |
Primary outcome
Effect of V3-P on tumor burden
Time frame: 3 months
Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-P in an open label trial in patients with inoperable pancreatic cancer.
2 secondary outcomes
Safety of V3-P
Time frame: 3 months
Effect of V3-P on sugar and bilirubin levels
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Background: PubMed 28443252Tarakanovskaya MG, Chinburen J, Batchuluun P, Munkhzaya C, Purevsuren G, Dandii D, Hulan T, Oyungerel D, Kutsyna GA, Reid AA, Borisova V, Bain AI, Jirathitikal V, Bourinbaiar AS. Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L. J Hepatocell Carcinoma. 2017 Apr 12;4:59-69. doi: 10.2147/JHC.S122507. eCollection 2017.
- Individual participant dataSharing planned: Undecided. The data will be shared with other researchers upon request on study conclusion
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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.
Allen Bain, PhD study chair
Immunitor Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing V3-P in people with Pancreatic Cancer Non-resectable, run by Immunitor LLC at 2 sites in Mongolia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mongolia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aldar Bourinbaiar, MD/PhD, PhD (+976-95130306, immunitor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of V3-P on tumor burden (time frame: 3 months). 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 NCT03165591, 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 30 Aug 2019.