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To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)

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ClinicalTrials.gov Identifier: NCT03220217
Recruitment Status : Completed
First Posted : July 18, 2017
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE June 26, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE September 20, 2017
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
Difference in relative lesion counts [ Time Frame: Day 1, day 16 to 22 ]
For each combination of injected peptide/radioactivity dose range, differences in relative lesion counts derived from a 2 × 3 factorial analysis measuring the ratio of the number of lesions detected by 68Ga-OPS202 to the number of lesions assessed by standard-of-truth (descriptive analyses). The standard-of-truth in this study is the CT scan images acquired at Visit 2 (day 1 and Visit 3 (day 16 to 22).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03220217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Difference in image quality [ Time Frame: Day 1, day 16 to 22 ]
    For each combination of injected peptide/radioactivity dose range, differences in image quality derived from a 2 × 3 factorial analysis measuring the tumour-to-background ratio in each of the major anatomic sites (i.e., descriptive analyses for liver, lymph nodes, bone and lungs)
  • Difference in lesion SUVmax [ Time Frame: Day 1, day 16 to 22 ]
    Differences in lesion SUVmax between the two peptide mass dose ranges and the three radioactivity dose ranges measured in the most avid lesions (descriptive analyses for up to a maximum of five lesions per organ in liver, lymph nodes, bone and lungs)
  • Difference in absolute number of lesions [ Time Frame: Day 1, day 16 to 22 ]
    Differences of absolute number of lesions between the two peptide mass dose ranges and the three radioactivity dose ranges detected in each of the following anatomic sites: Primary site of GEP-NET, Lymph nodes, Liver, Axial/ appendicular skeleton and Lungs
  • Proportion of subjects experiencing at least one Adverse Event (AE) of any grade [ Time Frame: Duration of the study (up to 36 days) ]
    According to NCI CTCAE v5, including any Serious Adverse Events (SAEs) and suspected unexpected serious adverse reactions (SUSARs). All AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) and preferred term (PT) (as per most recent version)
  • Proportion of subjects experiencing at least one AE of grade ≥3 [ Time Frame: Duration of the study (up to 36 days) ]
    According to NCI CTCAE v5
  • OPS202 plasma concentration [ Time Frame: Baseline pre-dose (day 0), up to 6 hours after 68Ga-OPS202 administration between day 1 and day 22 ]
  • Renal excretion of OPS202 in urine [ Time Frame: 0 hours up to 6 hours after 68Ga-OPS202 administration between day 1 and day 22 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • Difference in image quality [ Time Frame: Day 1, day 16 to 22 ]
    For each combination of injected peptide/radioactivity dose range, differences in image quality derived from a 2 × 3 factorial analysis measuring the tumour-to-background ratio in each of the major anatomic sites (i.e., descriptive analyses for liver, lymph nodes and bone)
  • Difference in lesion SUVmax [ Time Frame: Day 1, day 16 to 22 ]
    Differences in lesion SUVmax between the two peptide mass dose ranges and the three radioactivity dose ranges measured in the most avid lesions (descriptive analyses for up to a maximum of five lesions per organ)
  • Difference in absolute number of lesions [ Time Frame: Day 1, day 16 to 22 ]
    Differences of absolute number of lesions between the two peptide mass dose ranges and the three radioactivity dose ranges detected in each of the following anatomic sites: Primary site of GEP-NET, Lymph nodes, Liver, Axial/ appendicular skeleton and Lungs
  • Proportion of subjects experiencing at least one Adverse Event (AE) of any grade [ Time Frame: Duration of the study (up to 36 days) ]
    According to NCI CTCAE v4.03, including any Serious Adverse Events (SAEs) and suspected unexpected serious adverse reactions (SUSARs). All AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) and preferred term (PT) (as per most recent version)
  • Proportion of subjects experiencing at least one AE of grade ≥3 [ Time Frame: Duration of the study (up to 36 days) ]
    According to NCI CTCAE
  • OPS202 plasma concentration [ Time Frame: Baseline pre-dose (day 0), up to 6 hours after 68Ga-OPS202 administration between day 1 and day 22 ]
  • Renal excretion of OPS202 in urine [ Time Frame: 0 hours up to 6 hours after 68Ga-OPS202 administration between day 1 and day 22 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
Official Title  ICMJE A Multicentre, Randomised, Dose-confirmation, Factorial Phase II Study to Evaluate the Optimal Dose of 68Ga-OPS202 as a PET Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
Brief Summary The purpose of this clinical research is to define the optimal dose of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-OPS202 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
All the primary and secondary imaging endpoints are read by third-party independent readers. Most of the reading will be conducted in blinded manner.
Primary Purpose: Diagnostic
Condition  ICMJE Gastro-Enteropancreatic Neuroendocrine Tumor
Intervention  ICMJE Drug: Satoreotide trizoxetan
Positron emission tomography (PET) imaging agent
Other Name: 68Ga-OPS202
Study Arms  ICMJE
  • Experimental: 5-20μg/40-80 MBq, 30-45μg/100-140 MBq
    Subjects will receive a first intravenous (i.v.) injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 40 to 80 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 100 to 140 MBq.
    Intervention: Drug: Satoreotide trizoxetan
  • Experimental: 5-20μg/100-140 MBq, 30-45μg/160-200 MBq
    Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 100 to 140 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 160 to 200 MBq.
    Intervention: Drug: Satoreotide trizoxetan
  • Experimental: 5-20μg/160-200 MBq, 30-45μg/40-80 MBq
    Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 160 to 200 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 40 to 80 MBq.
    Intervention: Drug: Satoreotide trizoxetan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2019)
27
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2017)
25
Actual Study Completion Date  ICMJE August 5, 2019
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification 2010)
  • Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months prior to screening (Visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility
  • Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive
  • Adequate bone marrow, liver and renal function
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

  • Fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs
  • Subject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administration
  • Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
  • Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects unable to lie still for the entire imaging time, e) Subjects weighing greater than 110 kg (243 lb)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Denmark,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03220217
Other Study ID Numbers  ICMJE D-FR-01070-002
2016-004928-39 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP