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

Phase 2

Completed

• Conditions: euroendocrine tumour

• Registration Number: JPRN-jRCT2080222647
• Lead Sponsor: TEIJIN PHARMA LIMITED

Brief Summary

The safety and efficacy of lanreotide in this study indicated its usefulness as a treatment option for Japanese NET patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-07
• Study Completion: 2017-07-27
• Results First Posted: 2020-08-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 17

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>-

Secondary Outcome Measures

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