Phase 2 study of ITM-014 in patients with neuroendocrine tumour (Extension Study)

Phase 2, open-label study of ITM-014 in patients with neuroendocrine tumour (Extension Study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222647

Enrollment

Registered

2014-11-07

Start date

2014-12-03

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

Neuroendocrine tumour

Interventions

investigational material(s) Generic name etc : Lanreotide INN of investigational material : Lanreotide Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main Inclusion Criteria 1. Patients who have completed administration of the study drug designated in the preceding study by the time of registration 2. Patients who wish extended administration of ITM-014 3. Patients for whom the investigator or subinvestigator judges it medically not problematic to provide extended administration of ITM-014

Exclusion criteria

Exclusion criteria: Main Exclusion Criteria 1. Patients who have discontinued the preceding study by the time of registration. 2. Has other concurrent malignancy than neuroendocrine tumours 3. Cancer history of any malignancies, other than a neuroendocrine tumour (except for basocellular carcinoma of the skin or in-situ carcinoma of the uterus or the cervix), unless the patient has been in complete remission and with no relapse after the registration in the preceding study . 4. Patients with medical history of hypersensitive to somatostatin analogues 5. Patients with symptomatic cholelithiasis 6. Patients with liver dysfunction, renal dysfunction or severe heart disease 7. Women who are pregnant or breastfeeding, or suspected of being pregnant

Design outcomes

Primary

Measure	Time frame
safety -	—

Secondary

Measure	Time frame
safety efficacy Safety 1. Adverse events 2. Vital signs 3. Clinical laboratory tests 4. Test for antibody Efficacy 1. Progression-free survival (PFS) 2. Overall survival (OS) 3. Objective response rate (ORR) 4. Tumor shrinkage Safety(adverse events):NCI-CTCAE ver.4.0 Efficacy:RECIST(ver.1.1)	—

Countries

Japan

Outcome results

None listed

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