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

PDRadiopharma Inc.1 个研究点目标入组 13 人开始时间: 待定最近更新: 2022年5月20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:
•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
•Renal function: eGFR >= 30 mL/min/1.73 m2
•Liver function: AST < 100 IU/L, ALT < 100 IU/L, LDH < 400 IU/L
•Heart function: New York Heart Association (NYHA) Functional Classification <= I
•Metabolic function: HbA1c < 8.0% (NGSP)
•Respiratory function: SpO2 >= 96%
•ECOG Performance Status 0 or
•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.

efficacy Response rate of urinary catecholamines

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发起方

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