A phase I/II clinical study of F-1515 in combination with F-1520 in patients with somatostatin receptor positive, progressive midgut carcinoids and other neuroendocrine tumors
- Conditions
- Pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors
- Registration Number
- JPRN-jRCT2080223813
- 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
- 15
Histopathological diagnosis of midgut carcinoid, or NET of pancreas, gastrointestinal tract (excluding midgut carcinoid) 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 efficacy<br>pharmacokinetics<br>Pharmacokinetics and dosimetry of F-1515 administered as a single dose in combination with F-1520 infusion in patients with midgut carcinoid.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Clinical benefit rate (CBR), progression free survival (PFS), quality of life (QoL), and safety of F-1515 in combination with F-1520 infusion.
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