68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

NCT02162446 | Completed Phase 1 Results

• 2 other identifiers: OPS-B-0012014-001881-88
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)

  An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202.

  From start of IP administration to end of the study visit (approximately 28 to 36 days)

• Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication

  Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form.

  From start of IP administration to end of the study visit (approximately 28 to 36 days)

Secondary Outcomes (12)

• Number of Malignant and Benign Lesions Detected for Session 1

  6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21

• Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding

  At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21

• Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1

  6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21

• Mean SUVmax of Malignant and Benign Lesions for Session 2

  At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21

• Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1

  6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21

Study Arms (1)

68Ga-OPS202

EXPERIMENTAL

Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses

Drug: satoreotide trizoxetan

Interventions

satoreotide trizoxetan DRUG

Also known as: 68Ga-OPS202

68Ga-OPS202

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

University Hospital Basel

Basel, CH-4031, Switzerland

Location

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 12, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-09

Locations

CH (1)