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

TEIJIN PHARMA LIMITED0 个研究点目标入组 17 人开始时间: 2014年11月7日最近更新: 2023年10月17日

适应症

试验速览

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

•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

•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

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