Pheochromocytoma
Conditions
Interventions
investigational material(s)
Generic name etc : F-1614: 3-iodobenzylguanidine (I-131)
INN of investigational material : -
Therapeutic category code : 43- Radioactive medicines
Dosage and Administration
Sponsors
PDRadiopharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Comfirmed unresectable/metastatic/recurrent pheochromocytoma, paraganglioma, malignant pheochromocytoma, or malignant paraganglioma. - Presence of at least one measurable disease as defined by RECIST (ver.1.1). - Accumulation of 123I-MIBG to at least one target lesion documented by CT/MRI scans at screening. - For at least one of the following urinary catecholamines, the laboratory data is more than 3 times the upper limit of the normal range at screening: adrenaline, noradrenaline, metanephrine, or normetanephrine. - Patients must have sufficient organ functions meeting the following criteria at screening: 1) Bone marrow function: WBC >= 3,000/mm3 without G-CSF use, Hb >= 9.0 g/dL without transfusion, and PLT >= 100,000/mm3 without transfusion 2) Renal function: eGFR >= 30 mL/min/1.73 m2 3) Liver function: AST = 96% - ECOG Performance Status 0 or 1. - Expected survival of at least 6 months. - Patients who can take self-care while isolated in the radioisotope therapy ward. - Japanese patients aged >= 20 years at the time of informed consent.
Exclusion criteria
Exclusion criteria: - Previous MIBG therapy. - History of any surgery, CVD therapy, (chemo)embolization to hepatic metastases, medication to bone metastases, or external radiation within 8 weeks before enrollment. - History of uncontrollable adrenergic storm. - History of fatal arrhythmia or asystole. - Pregnant, within 28 days after giving birth, or breast-feeding patients (excluding breast-feeding patients who can agree to stop breast-feeding for 6 months after the administration of the study drug). - Patients who cannot agree to use contraceptive methods until 6 months after the administration of the study drug. - Presence or suspicious history of allergy to potassium iodine. - Participation in any other clinical study within 3 months before informed consent. - Patients assessed by the principal investigator or the subinvestigator as not appropriate as a subject of this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Response rate of urinary catecholamines | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Response rate of urinary catecholamines - Response rate of urinary catecholamine metabolites - Time course of changes in urinary catecholamines - Overall response rate assessed by RECIST ver.1.1 - Response rate assessed by I-123 MIBG scintigraphy - Quality of life - Safety | — |
Countries
Japan
Outcome results
None listed