Clinical Trials /

Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPSC001 in NETs

NCT02592707

Description:

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.

Related Conditions:
  • Colon Neuroendocrine Neoplasm
  • Colorectal Neuroendocrine Tumor
  • Gastric Neuroendocrine Tumor
  • Lung Neuroendocrine Neoplasm
  • Pancreatic Neuroendocrine Tumor
  • Paraganglioma
  • Pheochromocytoma
  • Small Intestinal Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPSC001 in NETs
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: OPS-C-001
  • SECONDARY ID: 2015-002867-41
  • SECONDARY ID: D-FR-01072-001
  • NCT ID: NCT02592707

Conditions

  • Neuroendocrine Tumors

Interventions

DrugSynonymsArms
Satoreotide tetraxetan177Lu-OPS201177Lu-OPS201

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.

Trial Arms

NameTypeDescriptionInterventions
177Lu-OPS201Experimental177Lu-OPS201 will be administered in 3 cycles at intervals of 8 weeks (+ up to 2 additional optional cycles)
  • Satoreotide tetraxetan

Eligibility 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 "typical lung carcinoid" or "atypical lung carcinoid" are acceptable
                  (with the exception of Large Cell Bronchial Neuroendocrine Neoplasms and Small
                  Cell Lung Cancers) (Caplin 2015).

               -  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 (although the progression might have
             occurred more than 6 months before study entry). 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. Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject
             at high risk of renal toxicity during the study as assessed by the investigator.

         10. 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).

         11. 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.

         12. 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

         13. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and Tolerability of 177Lu-OPS201 assessed by number of patients with treatment related adverse events using CTCAE v5.0
Time Frame:during the whole study period of 34 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Area under the curve (AUC) of 177Lu-OPS201 in discernible thoracic and abdominal organs, target lesion and blood
Time Frame:during the core study period of 10 months
Safety Issue:
Description:
Measure:Maximal uptake (achieved in %) at the target lesion.
Time Frame:during the core study period of 10 months
Safety Issue:
Description:
Measure:Maximal uptake (achieved in %) in discernible organs.
Time Frame:during the core study period of 10 months
Safety Issue:
Description:
Measure:Organs receiving the highest absorbed dose assessed by equivalent dose to tissue (HT; achieved in Sv).
Time Frame:during the core study period of 10 months
Safety Issue:
Description:
Measure:Specific absorbed dose per organ (achieved in μGy/MBq).
Time Frame:during the core study period of 10 months
Safety Issue:
Description:
Measure:Cumulative absorbed organ doses (achieved in Gy).
Time Frame:during the core study period of 10 months
Safety Issue:
Description:
Measure:Preliminary therapeutic efficacy of 177Lu-OPS201 assessed by tumor response based on RECIST v1.1
Time Frame:during the whole study period of 34 months
Safety Issue:
Description:
Measure: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 34 months
Safety Issue:
Description:
Measure:Quality of Life (QoL) questionnaire
Time Frame:during the core study period of 10 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ipsen

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