SSTr2 POSITIVE TUMORS MedDRA version: 20.1 Level: HLGT Classification code 10027655 Term: Miscellaneous and site unspecified neoplasms malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: LU-DOTATATE_IRSTIRCCS
Product Code: LU-DOTATATE_IRSTIRCCS
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: LU-DOTATATE_IRSTIRCCS
Current Sponsor code: LU-DOTATATE_IRSTIRCC
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years. 2. Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2-positive, that may benefit from receptor radionuclide therapy and for which there aren’t any other effective treatments. 3. Measurable disease according to RECIST 1.1.criteria; also patients without measurable but with evaluable disease can be enrolled. 4. Any disease stage is allowed. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan (the tumour uptake will be evaluated with a 3-grade scale, where 1 = liver uptake, 2 > liver uptake and kidney uptake: only tumour uptakes grade 2 and 3 will be considered for therapy) and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour. 5. Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed 6. Patients with or without concurrent therapy with somatostatin analogs 7. ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 208
Exclusion criteria
Exclusion criteria: 1. Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy). 2. Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry. 3. All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade = 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) 4. ECOG performance status >2 5. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 7. Assessed bone marrow invasion > 50% (with Bone Marrow biopsy or instrumental exams i.e bone scan or CT or MRI) 8. Pregnant or breastfeeding women are excluded from the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Progression free survival (PFS) 2) Safety;Secondary Objective: 1) Disease Control Rate (DCR) 2) frequency of late toxicity 3) Overal Survival (OS) in both arms 4) dosimetry in the 6 patient for each risk population (3 for each ARM) to measure pharmacokinetics, activity biodistribution and absorbed dose to kidneys (critical organ) and tumour. 5) To confirm the prognostic and predictive role of PET FDG in subgroup of GEP NET and bronchial NET patients. ;Primary end point(s): 1) PFS 2) Safety;Timepoint(s) of evaluation of this end point: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Prognostic and predictive role of PET FDG ;Timepoint(s) of evaluation of this end point: 5 years | — |
Countries
Italy
Contacts
Public ContactCentro di Coordinamento Studi IRST
IRST IRCCS
Outcome results
None listed