Spots Global Cancer Trial Database for Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors
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Trial Identification
Brief Title: Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors
Official Title: A Phase I/II Study Using Cabozantinib and Lanreotide as Treatment for Advanced Gastroenteropancreatic Neuroendocrine Tumors That Failed Molecular Targeted Therapies or Chemotherapy (SCALET)
Study ID: NCT05048901
Study Description
Brief Summary: This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one line of small molecule kinase inhibitor or chemotherapy.
Detailed Description: This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one line of small molecule kinase inhibitor or chemotherapy. The primary objective of the study is to determine the maximal tolerated dose (MTD) of cabozantinib of this combinational regimen in the phase I study and the progression free survival in the phase II study. The secondary objectives are the objective response rate, overall survival, toxicities and biomarker analysis of this regimen. Eligible patients will receive a combination of oral cabozantinib 40-60 mg/day and lanreotide 120mg deep subcutaneous injection (SC) in day 1 every 4 weeks. Four weeks is a cycle. The patients will continue to receive this regimen till disease progression, intolerable adverse events (after dose modification), death, or withdrawal by patients' or principle investigator's decision.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Changhua Christian Hospital, Changhua, , Taiwan
Chang Gung Medical Foundation, Kaohsiung, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospita, Tainan, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation, Taoyuan, , Taiwan
Contact Details
Name: Hui-Jen Tsai, PhD
Affiliation: National Health Research Institutes, Taiwan
Role: PRINCIPAL_INVESTIGATOR
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