Pancreatic Ductal AdenocarcinomaEarly Phase 1NCT01962909
Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer
A Early Phase 1 study testing PTP-01 in people with Pancreatic Ductal Adenocarcinoma, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- PTP-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2016
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)
- subject must have adequate renal function
- ECOG performance status of 0-2
- women of child-bearing age and men must agree to use contraception prior to and during the study
Who cannot join
- subjects receiving any other investigational agents
- significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Phase 0, Open Label Study to Evaluate the Biodistribution and Pharmacokinetics of a Single Intravenous Bolus Dose of PTP-01 in Subjects With Resectable Pancreatic Ductal Adenocarcinoma
The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- PTP-01
- Keywords
- Pancreatic Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTP-01Drug
Dose level 1 is 10mCi (50ug of peptide)
| Study group | Role | What they receive |
|---|---|---|
| PTP-01 | Experimental | single IV bolus dose 24 hours prior to surgery Receives: Drug: PTP-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of PTP-01 to detect pancreatic ductal adenocarcinoma
requires a signal to background ratio of greater than or equal to 2:1 following a single intravenous bolus of PTP-01
Measured: up to 72 hours post dose
Secondary outcomes (3)
Biodistribution and Binding Characteristics of PTP-01
Assessments will be made from imaging (whole body planar and SPECT/CT) and blood draws following PTP-01 dose. Tissue samples will also be retained for pathology.
Measured: up to 7 days post dose
Clearance of PTP-01
Blood and urine samples will be collected to measure the level of radioactivity at specified intervals following PTP-01 dose.
Measured: up to 7 days post dose
Safety and Tolerability of PTP-01
Clincial labs, ECGs, vital signs and physical exams will be performed up to 7 days post dose. Adverse events will be collected up to 30 days post dose.
Measured: up to 30 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: From preliminary imaging data, the study was stopped due to futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reid Adams, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962909
- Sponsor's protocol ID
- 16678
- Status last verified
- Mar 2016
- First submitted
- 19 Jun 2013
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, Open Label Study to Evaluate the Biodistribution and Pharmacokinetics of a Single Intravenous Bolus Dose of PTP-01 in Subjects With Resectable Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01962909
- Acronym / sponsor ID
- 16678
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreatic Resection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: From preliminary imaging data, the study was stopped due to futility.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Oct 2013 (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.
The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTP-01 | Experimental | Drug: PTP-01single IV bolus dose 24 hours prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)
- subject must have adequate renal function
- ECOG performance status of 0-2
- women of child-bearing age and men must agree to use contraception prior to and during the study
Key exclusion criteria (3 listed)
- subjects receiving any other investigational agents
- significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
- pregnant or breastfeeding women
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 |
|---|---|---|
| PTP-01Dose level 1 is 10mCi (50ug of peptide) | Drug | PTP-01 |
Primary outcome
Ability of PTP-01 to detect pancreatic ductal adenocarcinoma
Time frame: up to 72 hours post dose
requires a signal to background ratio of greater than or equal to 2:1 following a single intravenous bolus of PTP-01
3 secondary outcomes
Biodistribution and Binding Characteristics of PTP-01
Time frame: up to 7 days post dose
Clearance of PTP-01
Time frame: up to 7 days post dose
Safety and Tolerability of PTP-01
Time frame: up to 30 days post dose
Results and safety
The study was stopped early (reason given: From preliminary imaging data, the study was stopped due to futility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
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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.
Reid Adams, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PTP-01 in people with Pancreatic Ductal Adenocarcinoma, run by University of Virginia at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 18 Mar 2016. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: From preliminary imaging data, the study was stopped due to futility.). Results are not available in the source record.
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?
Ability of PTP-01 to detect pancreatic ductal adenocarcinoma (time frame: up to 72 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2016.