臨床研究等提出・公開システム

A phase I clinical study of F-1515 in combination with F-1520 in patients with somatostatin receptor positive, progressive pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors

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Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku2@novartis.com

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

completed

June. 28, 2017

Interventional

Open-label, uncontrolled, single-center

treatment purpose

1

- 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.

Both

Pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors

investigational material(s)
Generic name etc : F-1515
INN of investigational material : lutetium (177Lu) oxodotreotide
Therapeutic category code : 43- Radioactive medicines
Dosage and Administration for Investigational material : Intravenous infusion
Generic name etc : F-1520
INN of investigational material : -
Therapeutic category code : 799 Agents for not mainly purpose of therapeutic, n.e.c.
Dosage and Administration for Investigational material : Intravenous infusion

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

safety
pharmacokinetics
Safety, tolerability, pharmacokinetics and dosimetry of F-1515 administered as a single dose in combination with F-1520 infusion.

safety
efficacy
Safety and efficacy of F-1515 administered to the maximum dose (4 doses) in combination with F-1520 infusion.

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June. 20, 2017