NCT01994213

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 22, 2019

Status Verified

November 1, 2013

Enrollment Period

4.1 years

First QC Date

November 19, 2013

Last Update Submit

January 17, 2019

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Keywords

FamitinibGastroenteropancreatic Neuroendocrine TumorGEPNET

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    12 weeks

Secondary Outcomes (5)

  • Progress free survival (PFS)

    3 years

  • Disease Control Rate (DCR)

    3 years

  • Overall Survival (OS)

    3 years

  • Quality of Life

    28-day cycle visit until disease progress

  • Percent of Participants with OS of one year

    3 years

Study Arms (1)

Famitinib

EXPERIMENTAL

Famitinib 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.

Drug: Famitinib

Interventions

FamitinibDRUG

Famitinib 25 mg p.o. qd

Famitinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • neutrophils \< 1.5×10\^9/L
  • total bilirubin ≥ 1.25×ULN
  • serum transaminase(ALT and AST ) ≥ 1.5×ULN (If liver metastases are present, serum transaminase≥ 2.5×ULN)
  • creatinine clearance rate ≤ 60ml/min
  • cholesterol ≥ 1.5×ULN and triglyceride≥ 2.5 x ULN,
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Interventions

famitinib

Study Officials

  • Jinwan Wang, M.D.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

October 1, 2011

Primary Completion

November 1, 2015

Study Completion

May 1, 2016

Last Updated

January 22, 2019

Record last verified: 2013-11

Locations

CN(1)