A phase II clinical study of F-1614 in patients with pheochromocytoma (including paraganglioma)
- Conditions
- Pheochromocytoma
- Registration Number
- JPRN-jRCT2080223695
- Lead Sponsor
- PDRadiopharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 13
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method