Neuroendocrine TumorsNCT04334837
Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of SSTR Expressing (NETs)
A study testing Copper Cu 64 Dotatate in people with Neuroendocrine Tumors, run by Curium US LLC.
Trial summary
This is an open-label, multi-center expanded access program designed to provide access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of NETs to patients that did not have access during the Phase 3 Trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Copper Cu 64 Dotatate
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Patients of either sex, aged ≥18 years.
- Willing to sign the Informed Consent Form.
- Able to understand and comply with the procedures and requirements of the program.
- Meet at least one of the following criteria:
- Confirmed or suspicion of NET based on histology/biopsy report.
- Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET-CT scan and/or NaF PET-CT scan and/or OctreoScan® and/or clinical symptoms performed within 8 weeks prior to administration of Copper Cu 64 Dotatate.
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- Negative pregnancy test in women of child-bearing potential, using urine (dip stick test) or blood based testing (within 48 hours of injection).
- For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods for at least 2 weeks following administration of investigational product.
- For men, agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures for at least 2 weeks following administration of investigational product.
- Recent blood test results (within 4 weeks pre-dose) as follows:
- WBC: >2 x 109/L
- Hemoglobin: >8.0g/dL
- Platelets: >50 x 109/L
- ALT, AST, AP: ≤5 times ULN
- Bilirubin: ≤3 times ULN
- Serum creatinine: <170 μmol/L
Who cannot join
- Pregnant, planning to be pregnant within the next two weeks.
- Therapeutic use of any somatostatin analogue, including Sandostatin® LAR and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to administration with Copper Cu 64 Dotatate. If a patient is on Sandostatin® LAR or Lanreotide, a wash-out period of 28 days is required before the injection of the investigational product.
- History or presence of significant hematological abnormalities or immunodeficiency or any condition that might compromise the immune system (infections, vaccinations), of any etiology as indicated by clinically significantly abnormal values of any of the following hematologic parameters: platelets, hemoglobin, WBC count and ANC.
- Lactating and breast-feeding women.
- Acute or chronic clinically significant conditions such as uncontrolled congestive heart failure (rule out with MUGA scan, if suspected), liver or kidney dysfunction, uncontrolled hypertension.
- History of hypersensitivity to drugs with a similar chemical structure to the investigational product or any of its excipients.
- History of significant drug abuse within 1 year prior to administration of Copper Cu 64 Dotatate. Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to administration of Copper Cu 64 Dotatate.
- Participation in other clinical research trials involving evaluation of other investigational treatments within 30 days prior to administration of Copper Cu 64 Dotatate and/or unwilling to allow at least one week before participation in another drug trial following administration of Copper Cu 64 Dotatate.
About this study
Official title: An Open-Label, Multi-Center Expanded Access Protocol of Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of Somatostatin Receptor Expressing Neuroendocrine Tumors (NETs)
This is an open-label, multi-center expanded access program designed to provide access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of NETs to patients that did not have access during the Phase 3 Trial.
Read the detailed description
The objective of this trial is to provide patients with confirmed or suspicion of NET access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of SSTR expressing NETs, bridging the gap between investigational product availability in clinical studies and marketed product availability following US Food and Drug Administration (FDA) approval.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Copper Cu 64 Dotatate
- Keywords
- Somatostatin, 64Cu-DOTATATE, Neuroendocrine, PET/CT, PET/CT in oncology, Radiopharmaceuticals, Cu-64, Copper-64
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper Cu 64 DotatateDiagnostic test
The drug product contains Copper Cu 64 Dotatate filled in a glass vial, closed with butyl rubber stopper secured with an aluminum crimp seal. The drug product will be delivered by Curium to the clinical site. The EAP drug will be administered as an intravenous bolus injection. The dose will be administered according to the schedule detailed in the protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Curium US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334837
- Sponsor's protocol ID
- CURCu64Dot0001
- Status last verified
- Oct 2020
- First submitted
- 2 Apr 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Expanded Access Protocol of Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of Somatostatin Receptor Expressing Neuroendocrine Tumors (NETs)
- ClinicalTrials.gov ID
- NCT04334837
- Acronym / sponsor ID
- CURCu64Dot0001
- Conditions
- Neuroendocrine Tumors
- Keywords
- Somatostatin, 64Cu-DOTATATE, Neuroendocrine, PET/CT, PET/CT in oncology, Radiopharmaceuticals, Cu-64, Copper-64
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Curium US LLCIndustry (pharma, biotech, devices)
- First posted
- 6 Apr 2020 (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.
This is an open-label, multi-center expanded access program designed to provide access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of NETs to patients that did not have access during the Phase 3 Trial.
Detailed description
The objective of this trial is to provide patients with confirmed or suspicion of NET access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of SSTR expressing NETs, bridging the gap between investigational product availability in clinical studies and marketed product availability following US Food and Drug Administration (FDA) approval.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients of either sex, aged ≥18 years.
- Willing to sign the Informed Consent Form.
- Able to understand and comply with the procedures and requirements of the program.
- Meet at least one of the following criteria:
- Negative pregnancy test in women of child-bearing potential, using urine (dip stick test) or blood based testing (within 48 hours of injection).
Key exclusion criteria (8 listed)
- Pregnant, planning to be pregnant within the next two weeks.
- Therapeutic use of any somatostatin analogue, including Sandostatin® LAR and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to administration with Copper Cu 64 Dotatate. If a patient is on Sandostatin® LAR or Lanreotide, a wash-out period of 28 days is required before the injection of the investigational product.
- History or presence of significant hematological abnormalities or immunodeficiency or any condition that might compromise the immune system (infections, vaccinations), of any etiology as indicated by clinically significantly abnormal values of any of the following hematologic parameters: platelets, hemoglobin, WBC count and ANC.
- Lactating and breast-feeding women.
- Acute or chronic clinically significant conditions such as uncontrolled congestive heart failure (rule out with MUGA scan, if suspected), liver or kidney dysfunction, uncontrolled hypertension.
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 |
|---|---|---|
| Copper Cu 64 DotatateThe drug product contains Copper Cu 64 Dotatate filled in a glass vial, closed with butyl rubber stopper secured with an aluminum crimp seal. The drug product will be delivered by Curium to the clinical site. The EAP drug will be administered as an intravenous bolus injection. The dose will be administered according to the schedule detailed in the protocol. | Diagnostic test | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Copper Cu 64 Dotatate in people with Neuroendocrine Tumors, run by Curium US LLC.
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 16 inclusion and 8 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 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 9 Oct 2020.