Pancreas CancerPhase 1NCT04833959
Pilot Study of 89-Zr Panitumumab in Pancreas Cancer
A Phase 1 study testing 89Zr-panitumumab in people with Pancreas Cancer, run by Stanford University at 1 site in United States.
Trial summary
The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- 89Zr-panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to Mar 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of pancreatic cancer.
Who cannot join
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- History of infusion reactions to monoclonal antibody therapies.
- Pregnant or breastfeeding.
- Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Severe renal disease or anuria.
- Known hypersensitivity to deferoxamine or any of its components.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of 89Zr Panitumumab in Pancreas Cancer
The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer.
- Conditions
- Pancreas Cancer
- Being tested
- 89Zr-panitumumab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-panitumumabDrug
Imaging Agent
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-Panitumumab | Experimental | Subjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection. Receives: Drug: 89Zr-panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events assessed by CTCAE v5
Safety is defined by the number of CTCAE v5 grade 2 or higher adverse events by Day 7 determined that are significant, definitely, probably or possibly related to 89Zr-panitumumab. Safety data will be summarized by grade, severity, and type.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start26 Mar 2021
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrei Iagaru, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833959
- Sponsor's protocol ID
- IRB-57641
- Other IDs
- PANC0037, NCI-2021-03447
- Status last verified
- Jun 2024
- First submitted
- 2 Apr 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of 89Zr Panitumumab in Pancreas Cancer
- ClinicalTrials.gov ID
- NCT04833959
- Acronym / sponsor ID
- IRB-57641
- Conditions
- Pancreas Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Apr 2021 (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.
The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-Panitumumab | Experimental | Drug: 89Zr-panitumumabSubjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of pancreatic cancer.
Key exclusion criteria (7 listed)
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- History of infusion reactions to monoclonal antibody therapies.
- Pregnant or breastfeeding.
- Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
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 |
|---|---|---|
| 89Zr-panitumumabImaging Agent | Drug | 89Zr-Panitumumab |
Primary outcome
Incidence of treatment emergent adverse events assessed by CTCAE v5
Time frame: 7 days
Safety is defined by the number of CTCAE v5 grade 2 or higher adverse events by Day 7 determined that are significant, definitely, probably or possibly related to 89Zr-panitumumab. Safety data will be summarized by grade, severity, and type.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Andrei Iagaru principal investigator
Stanford Universiy
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 89Zr-panitumumab in people with Pancreas Cancer, run by Stanford University 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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 21 Jun 2024. 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?
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of treatment emergent adverse events assessed by CTCAE v5 (time frame: 7 days). 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 21 Jun 2024.