A phase II clinical study of F-1614 in patients with pheochromocytoma (including paraganglioma)

PDRadiopharma Inc.0 个研究点目标入组 13 人开始时间: 2017年10月30日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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 < 100 IU/L, ALT < 100 IU/L, LDH < 400 IU/L
•4) Heart function: New York Heart Association (NYHA) Functional Classification <= I
•5) Metabolic function: HbA1c < 8.0% (NGSP)
•6) Respiratory function: SpO2 >= 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.

•- 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.

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