Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Health Research Institutes, Taiwan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed G1 or G2 NET of GEP origin with locally advanced or metastatic stage who failed to one line or more than one line of small molecular kinase inhibitor (mTOR inhibitor or other targeted kinase inhibitor) or W-D G3 NET of GEP origin with locally advanced or metastatic stage who failed to one line or more than one line of chemotherapy or small molecule kinase inhibitor.
Radiologic progression within 12 months of entry
Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
Age≥ 20 years old and ECOG Performance Status ≤ 1.
Disqualifiers
Prior use of cabozantinib. (prior use of lanreotide is acceptable)
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before first dose of study treatment.
Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before first dose of study treatment.
Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Trial design
Design model
Single group
Treatments tested in this trial
Cabozantinib
DrugOral Cabozantinib 40-60 mg daily .every 4 weeks as a cycle
Lanreotide
DrugLanreotide 120 mg deep SC on day 1 every 4 weeks.every 4 weeks as a cycle
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Cabozantinib and LanreotideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
to determine the maximal tolerated dose of cabozantinib
The dose of maximal tolerated dose of carbozantinib combination of cabozantinib and lanreotide for the recommended dose in phase II study.
Time frame
Phase I last patient in has been treated for 28 days2
Progression free survival
The date of first study treatment to the date of disease progression.
Time frame
The time from registration to occurrence of progression based on the tumor response assessment by scheduled or un- scheduled CT scan or MRI. (whichever occurs first assessed up to 72 months)Secondary outcomes
1
Response rate
Estimates of response category frequencies with 95% confidence intervals will be computed.
Time frame
Every 8 weeks for first 4 cycles then every 3 cycles (12 weeks) until disease progress. (each cycle is 28 days)2
Overall survival
the time from the date of first study treatment to the date of patient death, due to any cause, or to the last date the patient was known to be alive.
Time frame
The time from registration to death from any cause assessed up to 72 months.3
Toxicities
Treatment toxicities and safety profiles,assessed by CTCAE v5.0
Time frame
Approximately 72 months.4
Genetic study
Genetic study assessed by Next Generation Sequencing
Time frame
Approximately 72 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Health Research Institutes, Taiwan
Lead sponsor
National Taiwan University Hospital
Collaborator
Taipei Veterans General Hospital, Taiwan
Collaborator
Mackay Memorial Hospital
Collaborator
Tri-Service General Hospital
Collaborator
Changhua Christian Hospital
Collaborator
China Medical University Hospital
Collaborator
National Cheng-Kung University Hospital
Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborator
Taichung Veterans General Hospital
Collaborator
Source ClinicalTrials.gov