Phase 2, open-label study of ITM-014 in patients with neuroendocrine tumour

TEIJIN PHARMA LIMITED0 个研究点目标入组 32 人开始时间: 2013年12月12日最近更新: 2023年10月17日

适应症

试验速览

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

•Main Inclusion Criteria
•1. Has a histologically proven neuroendocrine tumour
•2. Has an unresectable (or if the patient refuses surgery) metastatic or locally advanced neuroendocrine tumour
•3. Has a World Health Organization (WHO) performance status lower or equal to 2

•Main Exclusion Criteria
•1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma and goblet cell carcinoid
•2. Has been treated with peptide receptor radionucleotide therapy (PRRT)
•3. Has other concurrent malignancy than neuroendocrine tumours
•4. 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 for >= 5 years (and with no relapse) after curative cancer treatment
•5. Patients with medical history of hypersensitive to somatostatin analogues
•6. Patients with symptomatic cholelithiasis
•7. Patients with liver dysfunction, renal dysfunction or severe heart disease
•8. Women who are pregnant or breastfeeding, or suspected of being pregnant

发起方