HER2-positive CarcinomaPhase 1NCT03109977
Imaging With a New Agent That Finds a Cancer Protein Called HER2
A Phase 1 study testing Zr-DFO-pertuzumab PET/CT in people with HER2-positive Carcinoma and HER2-positive Primary Malignancy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HER2-positive Carcinoma, HER2-positive Primary Malignancy
- What is being tested?
- Zr-DFO-pertuzumab PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 12 Apr 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or greater
- Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate.
- At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
- ECOG performance of 0-2
Who cannot join
- Life expectancy < 3 months
- Pregnancy or lactation
- Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Slaon-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: First-in-human Imaging With 89Zr-DFO-pertuzumab in Patients With HER2 Positive Malignancies
The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.
- Being tested
- Zr-DFO-pertuzumab PET/CT
- Keywords
- 17-059, Zr-DFO-pertuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zr-DFO-pertuzumab PET/CTDrug
Zr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy
| Study group | Role | What they receive |
|---|---|---|
| Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT | Experimental | Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT will be performed in patients with known HER2-positive malignancy. Patients with multifocal disease, as demonstrated on cross-sectional imaging studies, will be preferentially recruited. Receives: Drug: Zr-DFO-pertuzumab PET/CT |
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, including vital signs as Assessed by CTCAE v4.0
Patients will be monitored closely for evidence of adverse events, including vital signs before and after tracer administration. The day after tracer administration, a physician will screen for any side effects requiring treatment. If a severe adverse effect (Common Terminology Criteria for Adverse Events grade 3 or 4) attributable to 89Zr-DFO-pertuzumab occurs in any patient, then further use of 89Zr-DFO-pertuzumab will be suspended and the protocol reviewed with the MSKCC Data Safety Monitoring Committee.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start31 Mar 2017
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Ulaner, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109977
- Sponsor's protocol ID
- 17-059
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human Imaging With 89Zr-DFO-pertuzumab in Patients With HER2 Positive Malignancies
- ClinicalTrials.gov ID
- NCT03109977
- Acronym / sponsor ID
- 17-059
- Keywords
- 17-059, Zr-DFO-pertuzumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 12 Apr 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.
The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT | Experimental | Drug: Zr-DFO-pertuzumab PET/CTZr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT will be performed in patients with known HER2-positive malignancy. Patients with multifocal disease, as demonstrated on cross-sectional imaging studies, will be preferentially recruited. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 years or greater
- Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate.
- At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
- ECOG performance of 0-2
Key exclusion criteria (3 listed)
- Life expectancy < 3 months
- Pregnancy or lactation
- Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
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 |
|---|---|---|
| Zr-DFO-pertuzumab PET/CTZr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy | Drug | Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT |
Primary outcome
Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0
Time frame: 1 year
Patients will be monitored closely for evidence of adverse events, including vital signs before and after tracer administration. The day after tracer administration, a physician will screen for any side effects requiring treatment. If a severe adverse effect (Common Terminology Criteria for Adverse Events grade 3 or 4) attributable to 89Zr-DFO-pertuzumab occurs in any patient, then further use of 89Zr-DFO-pertuzumab will be suspended and the protocol reviewed with the MSKCC Data Safety Monitoring Committee.
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 17 Apr 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Gary Ulaner, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 Zr-DFO-pertuzumab PET/CT in people with HER2-positive Carcinoma and HER2-positive Primary Malignancy, run by Memorial Sloan Kettering Cancer Center 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: finished, as of the sponsor's last update on 17 Apr 2018. 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 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, including vital signs as Assessed by CTCAE v4.0 (time frame: 1 year). 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 17 Apr 2018.