Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of SSTR Expressing (NETs)

October 8, 2020 updated by: Curium US LLC

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

    1. Confirmed or suspicion of NET based on histology/biopsy report.
    2. 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.
  • 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:

    1. WBC: >2 x 109/L
    2. Hemoglobin: >8.0g/dL
    3. Platelets: >50 x 109/L
    4. ALT, AST, AP: ≤5 times ULN
    5. Bilirubin: ≤3 times ULN
    6. Serum creatinine: <170 μmol/L

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Curium US LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CURCu64Dot0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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