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Gastroenteropancreatic Neuroendocrine TumorPhase 2NCT01994213

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

A Phase 2 study testing Famitinib in people with Gastroenteropancreatic Neuroendocrine Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Famitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
Oct 2011to May 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 27Show fewer
  • 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,
  • LVEF: < 50% by Color Doppler Ultrasonography
  • Patients with uncontrollable hypertension after using single agent therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg). Patients with more than Class I, myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 450ms for male and 470ms for female) and class I heart failure.
  • Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g
  • Long-term untreated wounds or fractures
  • Coagulopathy with bleeding tendency (such as active peptic ulcer)
  • Previous artery / venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism
  • Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (less than 100mg daily) is allowed
  • Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.
  • Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
  • Abuse of psychiatric drugs or dysphrenia
  • Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing

Other trials in China

About this study

Official title: 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

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.

Being tested
Famitinib
Keywords
Famitinib, Gastroenteropancreatic Neuroendocrine Tumor, GEPNET
Medical subject headings
Gastro-enteropancreatic neuroendocrine tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FamitinibDrug

    Famitinib 25 mg p.o. qd

Study groups in NCT01994213
Study groupRoleWhat they receive
FamitinibExperimentalFamitinib 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
Receives: Drug: Famitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Measured: 12 weeks

Secondary outcomes (5)

  1. Progress free survival (PFS)

    Measured: 3 years

  2. Disease Control Rate (DCR)

    Measured: 3 years

  3. Overall Survival (OS)

    Measured: 3 years

  4. Quality of Life

    Measured: 28-day cycle visit until disease progress

  5. Percent of Participants with OS of one year

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startOct 2011
  3. Primary completionNov 2015
  4. Study completionMay 2016

Why it stopped: The applicant decided to close the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01994213
Sponsor's protocol ID
FMTN- Ⅱ- GEPNET
Status last verified
Nov 2013
First submitted
19 Nov 2013
Last updated
22 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Famitinib in people with Gastroenteropancreatic Neuroendocrine Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The applicant decided to close the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01994213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.

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