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Trial record 1 of 1 for:    Recruiting Studies | OPS-201 | Australia
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Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPSC001 in NETs

This study is currently recruiting participants.
Verified September 2017 by Ipsen
Sponsor:
ClinicalTrials.gov Identifier:
NCT02592707
First Posted: October 30, 2015
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  Purpose
The purpose of this clinical phase I/II study is to investigate the safety and tolerability of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs). Secondary objectives of these study are the assessment of biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201.

Condition Intervention Phase
Neuroendocrine Tumors Drug: 177Lu-OPS201 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Safety and Tolerability of 177Lu-OPS201 assessed by number of patients with treatment related adverse events using CTCAE v4.0 [ Time Frame: during the whole study period of 32 months ]

Secondary Outcome Measures:
  • AUC of 177Lu-OPS201 in discernible thoracic and abdominal organs, target lesion and blood [ Time Frame: during the core study period of 8 months ]
  • Maximal uptake (achieved in %) at the target lesion. [ Time Frame: during the core study period of 8 months ]
  • Maximal uptake (achieved in %) in discernible organs. [ Time Frame: during the core study period of 8 months ]
  • Organs receiving the highest absorbed dose assessed by equivalent dose to tissue (HT; achieved in Sv). [ Time Frame: during the core study period of 8 months ]
  • Specific absorbed dose per organ (achieved in μGy/MBq). [ Time Frame: during the core study period of 8 months ]
  • Cumulative absorbed organ doses (achieved in Gy). [ Time Frame: during the core study period of 8 months ]
  • Preliminary therapeutic efficacy of 177Lu-OPS201 assessed by tumor response based on RECIST v1.1 [ Time Frame: during the whole study period of 32 months ]
  • Preliminary therapeutic efficacy of 177Lu-OPS201 assessed by monitoring of PFS (based on RECIST v1.1 status) [ Time Frame: during the whole study period of 32 months ]
  • Quality of Life (QoL) questionnaire [ Time Frame: during the core study period of 8 months ]

Estimated Enrollment: 45
Actual Study Start Date: March 6, 2017
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 177Lu-OPS201
177Lu-OPS201 will be administered in 3 cycles at intervals of 8 weeks
Drug: 177Lu-OPS201
177Lu-OPS201 will be administered in 3 cycles at intervals of 8 weeks

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Written informed consent.
  2. Patients of either gender, aged ≥ 18 years.
  3. Women of childbearing potential (not surgically sterile or less than 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after the last dose. Acceptable methods of contraception include abstinence, or double contraception: steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method (intrauterine device, condom etc.).
  4. Male patients must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after the last activity administration.
  5. Karnofsky performance score ≥ 60.
  6. Life expectancy of at least 6 months.
  7. Histologically confirmed diagnosis of -

    • unresectable GEP NET (Grade I and Grade II according to WHO classification (2010, Annex 01), functioning and non-functioning).
    • unresectable lung NET Grade I and Grade II (low and intermediate grade) (Klimstra et al 2010)
    • malignant, unresectable pheochromocytoma or paraganglioma
  8. Documentation of progressive disease based on RECIST v1.1 under prior anti-tumor therapy within 6 months of entry in the study. Patients should not have received further anti-tumor therapy once disease progression is documented. The images of this evaluation should be available for TGR evaluation.
  9. In countries where sunitinib or everolimus are marketed, patients with GEP NET and lung NET will be progressive under this prior anti-tumor treatment for the respective indication. Patients not suitable for everolimus/sunitinib therapy according to a tumor board decision (or comparable local practice) may also be enrolled into the study. Patients having everolimus/sunitinib therapy should have a wash-out phase of ≥ 4 weeks before the first treatment.
  10. Measurable disease based on RECIST v1.1.
  11. Confirmed presence of somatostatin receptors on technically evaluable tumor lesions documented by a positive Somatostatin Receptor Scan performed within 6 months prior to enrolment in the study.
  12. Calculated GFR ≥ 55 mL/min.
  13. Blood test results as follows:

    • Leukocytes: ≥ 4*10^9/L
    • Erythrocytes: ≥ 3.5*12^9/L
    • Platelets: ≥ 100*10^9/L
    • Albumin: > 30 g/L
    • ALT, AST, AP: ≤ 5 times ULN (upper limit of normal)
    • Bilirubin: ≤ 2 times ULN (2x 1.1 mg/dL)

Exclusion Criteria:

  1. Known hypersensitivity to 177Lu, to DOTA, to JR11 or to any of the excipients of 177Lu-OPS201.
  2. Any previous peptide receptor radionuclide therapy (PRRT).
  3. Diagnosis of thymic NET.
  4. Presence of active infection at screening or history of serious infection within the previous 6 weeks.
  5. Administration of any other investigational medicinal product within 60 days prior to entry.
  6. Prior or planned administration of a therapeutic radiopharmaceutical within 8 half-lives of the radionuclide including any time during the current study.
  7. Any extensive radiotherapy ≤ 3 months before enrolment.
  8. Chemotherapy ≤ 3 months before enrolment.
  9. Pregnant or breast-feeding women: A pregnancy test will be performed at the start of the study for all female patients of childbearing potential (i.e. not surgically sterile or up to 2 years postmenopausal).
  10. Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus [HbA1c ≥9%], uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Note: the patient should be able to tolerate high volume load.
  11. Current history of any malignancy other than NET within 5 years of enrolment except for fully -resected non-melanoma skin cancer or cervical cancer in situ. Current history of malignancy; patients with a secondary tumor in remission of > 5 years can be included
  12. Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
  Contacts and Locations
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): NCT02592707


Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Australia
Peter MacCallum Cancer Centre, Molecular Imaging and Targeted Therapeutics Laboratory Recruiting
East Melbourne, Australia, 3002
Ramsay Hollywood Private Hospital, Department of Nuclear Medicine Recruiting
Perth, Australia, 6009
Austria
University Hospital Vienna, Department of Nuclear Medicine Not yet recruiting
Vienna, Austria, 1090
Denmark
University Hospital Aarhus, Department of Hepatology and Gastroenterology Recruiting
Aarhus, Denmark, 8000
Switzerland
University Hospital Basel, Department of Nuclear Medicine Not yet recruiting
Basel, Switzerland, 4031
United Kingdom
Royal Free Hospital, Department of Nuclear Medicine Recruiting
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Heike Oberwittler, Dr. Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02592707     History of Changes
Other Study ID Numbers: OPS-C-001
2015-002867-41 ( EudraCT Number )
D-FR-01072-001 ( Other Identifier: Ipsen Study Protocol Number )
First Submitted: October 15, 2015
First Posted: October 30, 2015
Last Update Posted: October 2, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial