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

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

No

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PDRadiopharma Inc.

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s-clinicaltrial-info@pdradiopharma.com

PDRadiopharma Inc.

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s-clinicaltrial-info@pdradiopharma.com

completed

Jan. 22, 2018

Interventional

Single arm, open-label, multicenter

treatment purpose

2

- 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.

Both

Pheochromocytoma

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 for Investigational material : F-1614 will be administered at a dose of 7.4 GBq by intravenous infusion. In case 7.4 GBq can not be administered due to radiation limit, at least 5.55 GBq should be administered.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
Response rate of urinary catecholamines

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

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Nov. 08, 2017