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TERMINATEDPHASE2

A Study of Famitinib in Patients With Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumor

A Randomized, Single-arm, Open-label, Multicenter, Phase II Study of Famitinib as First/Second Line Treatment in Patients With Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumor

NCT01994213•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable. The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in patients with advanced or metastatic Gastroenteropancreatic Neuroendocrine Tumor.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Unresectable advanced or metastatic, histologically-confirmed, gastroenteropancreatic neuroendocrine tumor. Tumors must be considered well-differentiated grade G1 or grade G2 in accordance with WHO 2010 classification.
•Must have at least one measurable disease by RECIST1.1 criteria(tumour lesions ≥10mm in longest diameter, malignant lymph nodes ≥15mm in short axis, scanning layer ≤ 5 mm).
•First-line therapy or second-line treatment (second-line treatment i.e. chemotherapy or cytokine therapy as first-line treatment failure or resistant patients).
•No previously received targeted therapy of gastroenteropancreatic neuroendocrine tumor (such as everolimus, sunitinib, or other tyrosine kinase or VEGF inhibitor treatment).
•Age between 18 and 75 years.
•ECOG Performance status ≤ 1.
•Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

•Patients with small-cell carcinoma, pheochromocytoma, paraganglioma or Merkel cell carcinoma
•Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ
•Participated in other clinical trials within four weeks
•Concurrent therapy with somatostatin analogs(such as octreotide, lanreotide,etc.)
•A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction)
•Known brain metastases, spinal cord compression, cancer, meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
•Subjects received surgery, chemotherapy, radiation therapy, cytokines treatment caused the damage has not been restored, the time interval ≤ 4 weeks, and the wound has not completely healed
•Participants have inadequate organ and marrow function as defined below:
•* hemoglobin \< 90g/L
•* platelets \< 100×10\^9/L
+17 more criteria

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Key Dates

Start Date

October 1, 2011

Primary Completion Date

November 1, 2015

Completion Date

May 1, 2016

Last Updated

January 22, 2019

Enrollment

ACTUAL participants

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Interventions

Famitinib

DRUG

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ACTIVE_NOT_RECRUITING

Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

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Gastroenteropancreatic Neuroendocrine Tumor

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Famitinib in Patients With Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumor

Inclusion Criteria

Exclusion Criteria

IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers

Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

177Lutetium-octreotate Treatment Prediction Using Multimodality Imaging in Refractory NETs

TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET

Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)