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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223813

Enrollment

Registered

2018-02-16

Start date

2018-04-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors

Interventions

investigational material(s) Generic name etc : F-1515 INN of investigational material : lutetium (177Lu) oxodotreotide Therapeutic category code : 43- Radioactive medicines Dosage and Administration f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
efficacy pharmacokinetics Pharmacokinetics and dosimetry of F-1515 administered as a single dose in combination with F-1520 infusion in patients with midgut carcinoid.	—

Secondary

Measure	Time frame
safety efficacy Clinical benefit rate (CBR), progression free survival (PFS), quality of life (QoL), and safety of F-1515 in combination with F-1520 infusion.	—

Countries

Japan

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026