- Conditions
- Pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors
- Registration Number
- JPRN-jRCT2080223594
- Lead Sponsor
- FUJIFILM Toyama Chemical Co., Ltd. (Former FUJIFILM RI Pharma Co., Ltd.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 6
Histopathological diagnosis of NET of the pancreas, gastrointestinal tract, or lung.
- Patients must have metastatic or locally advanced disease not amenable to curative resection.
- Tumor progression confirmed within 12 months before enrollment.
- Presence of at least one measurable disease as defined by RECIST.
- Accumulation of 111In-pentetreotide in all target lesions exceeding the accumulation in the normal liver documented by whole-body planar imaging.
- History of systemic treatment with any antineoplastic agents (excluding somatostatin analogs) within 8 weeks before enrollment.
- History of any surgery, radiofrequency ablation, (chemo)embolization, or radioembolization within 12 weeks before enrollment.
- History of peptide receptor radionuclide therapy (PRRT) even once.
- History of external radiation therapy covering >= 25% bone marrow.
- Patients currently receiving treatment with somatostatin analog who are expected to have difficulty in temporarily discontinuing the treatment for a defined period before each dose of F-1515.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>Safety, tolerability, pharmacokinetics and dosimetry of F-1515 administered as a single dose in combination with F-1520 infusion.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety and efficacy of F-1515 administered to the maximum dose (4 doses) in combination with F-1520 infusion.