Breast CancerPhase 2NCT03697551
Define the Optimal Uptake Time of 68Ga-OPS202 When Used as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Newly Diagnosed Breast Cancer
A Phase 2 study testing Satoreotide trizoxetan in people with Breast Cancer, run by Ipsen at 1 site in Austria.
Trial summary
The purpose of this clinical research is to define the optimal uptake time of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize breast cancer somatostatin receptor subtype 2 (SSTR2) positive lesions. 68Ga-OPS202 is a radiolabelled imaging agent to be used in association with PET. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Satoreotide trizoxetan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteAustria
- Study dates
- 22 Oct 2018to 6 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Subjects with newly diagnosed (early or advanced) breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Adequate bone marrow, liver and renal function, with:
- Calculated glomerular filtration rate (GFR): ≥45 mL/min
- Albumin: >30 g/L
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- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤5 times upper limit of normal (ULN)
- Bilirubin: ≤3xULN (3×1.1 mg/dL)
- Leukocytes: ≥3x109/L, and neutrophils: ≥1x109/L
- Erythrocytes: ≥3.5x1012/L
- Platelets: ≥90x109/L
- Signed written informed consent prior to any study-related procedures.
Who cannot join
- Subject with resected primary tumour
- Subjects with confirmed ductal carcinoma in situ
- Men with breast cancer
- Presence of an active infection at screening or history of a serious infection within the previous 6 weeks prior to the first 68Ga-OPS202 administration that might interfere with the PET and/or CT analysis
- Subjects who have received any therapy for breast cancer
- Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
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- Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration
- Any condition that precludes the proper performance of PET and/or CT scan:
- Subjects who are not able to tolerate the CT contrast agent
- Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis
- Subjects unable to raise arms for prolonged imaging purposes
- Subjects unable to lie still for the entire imaging time
- Subjects weighing greater than 110 kg (243 lb)
- Known hypersensitivity to radiolabelled NODAGA (1,4,7- triazacyclononane,1-glutaric acid 4,7 acetic acid), to Gallium-68, to somatostatin analogue peptide JR11 or to any of the excipients of 68Ga- OPS202
- History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of systemic corticosteroids
- Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B or C
- Administration of another investigational medicinal product within 30 days prior to first 68Ga-OPS202 administration
- Subjects who are pregnant, breast feeding or of childbearing potential not willing to practice effective contraceptive techniques during the study treatment period and for 30 days after the last dose of 68Ga-OPS202 administration; pregnancy test must be performed at the start of the study and prior to 68Ga-OPS202 administration
- Subjects who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including any mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude
- Subject who experienced a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus), and/or subjects treated with curative intent and free from disease for more than 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Randomised Phase II Study to Evaluate the Optimal Uptake Time of 68GA-OPS202 as a sstr2 Positive PET Imaging Agent in Subjects With Newly Diagnosed Breast Cancer
The purpose of this clinical research is to define the optimal uptake time of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize breast cancer somatostatin receptor subtype 2 (SSTR2) positive lesions.
68Ga-OPS202 is a radiolabelled imaging agent to be used in association with PET. 68Ga-OPS202 is made of two main components: 1) OPS202, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium 68, a radioisotope that, combined with OPS202, can be seen in the PET scanner.
- Conditions
- Breast Cancer
- Being tested
- Satoreotide trizoxetan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satoreotide trizoxetanDrug
Also called 68Ga-OPS202, 68Ga-IPN01070
Subjects will receive a single dose of Satoreotide trizoxetan consisting of a peptide mass up to 45 μg, with a radioactivity range of 150-200 MBq. Satoreotide trizoxetan is intended for diagnostic use as a Positron emission tomography/computed tomography (PET/CT) tracer for the imaging of tumours expressing SSTR2.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-OPS202 | Experimental | A single dose of Satoreotide trizoxetan will be administered as a slow intravenous (i.v.) bolus injected over 1 minute at Baseline/Day 1. Receives: Drug: Satoreotide trizoxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint)
The percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion using 68Ga-satoreotide trizoxetan was to be determined.
Measured: At 0.5, 1.0 and 2.0 hours post injection on Day 1.
Differences in the Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint)
The differences in the number of lesions detected by 68Ga-satoreotide trizoxetan between the 3 PET acquisition timepoints, and reader interpretation was to be determined.
Measured: 0.5, 1.0 and 2.0 hours post injection on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start22 Oct 2018
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Why it stopped: Recruitment challenges and not due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697551
- Sponsor's protocol ID
- D-FR-01070-003
- Other IDs
- 2018-000028-33, 2018
- Status last verified
- Aug 2020
- First submitted
- 12 Jul 2018
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomised Phase II Study to Evaluate the Optimal Uptake Time of 68GA-OPS202 as a sstr2 Positive PET Imaging Agent in Subjects With Newly Diagnosed Breast Cancer
- ClinicalTrials.gov ID
- NCT03697551
- Acronym / sponsor ID
- D-FR-01070-003
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges and not due to safety concerns.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 7 Sep 2020
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 research is to define the optimal uptake time of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize breast cancer somatostatin receptor subtype 2 (SSTR2) positive lesions.
68Ga-OPS202 is a radiolabelled imaging agent to be used in association with PET. 68Ga-OPS202 is made of two main components: 1) OPS202, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium 68, a radioisotope that, combined with OPS202, can be seen in the PET scanner.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-OPS202 | Experimental | Drug: Satoreotide trizoxetanA single dose of Satoreotide trizoxetan will be administered as a slow intravenous (i.v.) bolus injected over 1 minute at Baseline/Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women aged 18 years or older
- Subjects with newly diagnosed (early or advanced) breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Adequate bone marrow, liver and renal function, with:
- Signed written informed consent prior to any study-related procedures.
Key exclusion criteria (20 listed)
- Subject with resected primary tumour
- Subjects with confirmed ductal carcinoma in situ
- Men with breast cancer
- Presence of an active infection at screening or history of a serious infection within the previous 6 weeks prior to the first 68Ga-OPS202 administration that might interfere with the PET and/or CT analysis
- Subjects who have received any therapy for breast 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 |
|---|---|---|
| Satoreotide trizoxetanAlso: 68Ga-OPS202, 68Ga-IPN01070Subjects will receive a single dose of Satoreotide trizoxetan consisting of a peptide mass up to 45 μg, with a radioactivity range of 150-200 MBq. Satoreotide trizoxetan is intended for diagnostic use as a Positron emission tomography/computed tomography (PET/CT) tracer for the imaging of tumours expressing SSTR2. | Drug | 68Ga-OPS202 |
Primary outcome
Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint)
Time frame: At 0.5, 1.0 and 2.0 hours post injection on Day 1.
The percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion using 68Ga-satoreotide trizoxetan was to be determined.
Differences in the Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint)
Time frame: 0.5, 1.0 and 2.0 hours post injection on Day 1
The differences in the number of lesions detected by 68Ga-satoreotide trizoxetan between the 3 PET acquisition timepoints, and reader interpretation was to be determined.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Satoreotide trizoxetan in people with Breast Cancer, run by Ipsen at 1 site in Austria.
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 12 inclusion and 20 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 7 Sep 2020. 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 Austria. 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 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?
Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint) (time frame: At 0.5, 1.0 and 2.0 hours post injection on Day 1.). The study lists 2 primary outcomes in all. 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 7 Sep 2020.