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68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

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ClinicalTrials.gov Identifier: NCT02162446
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).

Condition or disease Intervention/treatment Phase
Gastroenteropancreatic Neuroendocrine Tumors Drug: satoreotide trizoxetan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open-label, Micro-dosing Study to Evaluate Safety, Biodistribution, Dosimetry and Preliminary Efficacy of Two Single 68Ga-OPS202 Doses for the Diagnostic Imaging of Somatostatin Receptor-positive Gastro-entero-pancreatic Neuroendocrine Tumors (GEP NET) Using Positron-emission Tomography / Computed Tomography (PET/CT)
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Experimental: 68Ga-OPS202
Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses
Drug: satoreotide trizoxetan
Other Name: 68Ga-OPS202




Primary Outcome Measures :
  1. Safety and tolerability of 68Ga-OPS202 (laboratory parameters) [ Time Frame: 4 weeks before to 5 weeks after first dose of 68Ga-OPS202 ]
    Laboratory assessments will include hematology, blood biochemistry and urine analysis

  2. Safety and tolerability of 68Ga-OPS202 (vital signs) [ Time Frame: 4 weeks before to 5 weeks after first dose of 68Ga-OPS202 ]
    Vital signs will include systolic and diastolic blood pressure, heart rate and axillary body temperature

  3. Safety and tolerability of 68Ga-OPS202 (ECGs) [ Time Frame: 4 weeks before to 5 weeks after first dose of 68Ga-OPS202 ]
    Cardiac safety will be assessed by 12-lead ECGs

  4. Safety and tolerability of 68Ga-OPS202 as assessed by determination of number of patients with adverse events [ Time Frame: until 5 weeks after first dose of 68Ga-OPS202 ]

Secondary Outcome Measures :
  1. Determination of AUC0-last of 68Ga-OPS202 in discernible thoracic and abdominal organs, target lesion and blood [ Time Frame: 0 (pre-dose) to 4h post-dose ]
  2. Determination of Cmax (maximum concentration achieved in units of Bq/ml) for target lesion [ Time Frame: 0 (pre-dose) to 4h post-dose ]
  3. Determination of Cmax (maximum concentration achieved in units of Bq/ml) for discernible organs and blood [ Time Frame: 0 (pre-dose) to 4h post-dose ]
  4. Determination of Tmax for target lesion [ Time Frame: 0 (pre-dose) to 4h post-dose ]
    Determination of the time post-injection to achieve maximum tumor concentration

  5. Determination of Tmax for blood and organs [ Time Frame: 0 (pre-dose) to 4h post-dose ]
    Determination of the time post-injection to achieve maximum organ and blood concentration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available.
  • A somatostatin receptor scan with results in the previous 6 months prior to dosing day.
  • At least 1 lesion detected by the previous somatostatin receptor scan.
  • Not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan.
  • Blood test results as follows (WBC: ≥ 3*109/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x109/L, ALT, AST, AP: ≤ 5 times ULN, Bilirubin: ≤ 3 times ULN)
  • ECG: any abnormalities have to be clarified by a cardiologist.
  • Serum creatinine: within normal limits or < 120 μmol/L for patients aged 60 years or older.
  • Calculated GFR ≥ 45 mL/min.
  • Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria:

  • Known hypersensitivity to 68Ga, to NODAGA, to 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 corticosteroids.
  • Presence of active infection at screening or history of serious infection within the previous 6 weeks.
  • Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C.
  • Any condition that precludes raised arms position for prolonged imaging purposes.
  • Neuroendocrine tumor specific treatment between last somatostatin receptor imaging and start of this study. Exception is the therapeutic use of any somatostatin analog (see below).
  • Therapeutic use of any somatostatin analog, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on Sandostatin® a wash-out phase of 2 days is required before the injection of the study drug.
  • Administration of another investigational medicinal product within 30 days prior to entry.
  • Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
  • Current > grade 2 toxicity from previous standard or investigational therapies, per US-NCI "Common Terminology Criteria for Adverse Events v4.0".
  • Pregnant or breast-feeding women.
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
  • Current history of malignancy; patients with a secondary tumor in remission of > 5 years can be included.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162446


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02162446     History of Changes
Other Study ID Numbers: OPS-B-001
2014-001881-88 ( EudraCT Number )
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases