Neuroendocrine tumour
Conditions
Sponsors
TEIJIN PHARMA LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Clinical benefit rate (CBR) after 24 weeks of treatment RECIST(ver.1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics Efficacy 1. Progression-free survival (PFS) 2. Overall survival (OS) 3. Time to progression (TTP) 4. Objective response rate (ORR) 5. Tumor Shrinkage Safety 1. Adverse events 2. Vital signs 3. Clinical laboratory tests 4. Test for anti-lanreotide antibody Pharmacokinetics PK parameters Efficacy: RECIST(ver.1.1) Safety(adverse events): NCI-CTCAE ver.4.0 | — |
Countries
Japan
Outcome results
None listed