AzTrials
AzTrials

Gastrointestinal Stromal TumorPhase 2NCT02336724

A Study of Famitinib in Patients With Gastrointestinal Stromal Tumor

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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 gastrointestinal stromal tumor who… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastrointestinal Stromal Tumor
What is being tested?
Famitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
Mar 2012to Jun 2019
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, gastrointestinal stromal tumor.Patients has been failed from last imatinib treatment due to disease progression or unacceptable toxicity and unable to use sunitinib.
  • At least 2 weeks since the last imatinib administration
  • 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).
  • ECOG Performance status 0-1
  • Participants have adequate organ and marrow function as defined below:
  • neutrophils ≥ 1.5×10^9/L, platelets≥ 80×10^9/L, hemoglobin≥ 90g/L （no blood transfusion within 14 days), serum transaminase(ALT and AST ) ≤ 2.5×ULN (If liver metastases are present, serum transaminase≤5×ULN), total bilirubin ≤ 1.25×ULN, cholesterol ≤ 7.75mmol/L and triglyceride≤1 x ULN, creatinine ≤1x ULN,creatinine clearance rate > 50ml/min Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g normal serum calcium, potassium,magnesium, phosphorus INR≤1.5 and APTT≤1.5 ULN LVEF: ≥ 50%
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit
  • The toxicity from previous imatinib or other treatment has not been recovered ≤ grade 1 according to CTCAE 3.0
  • Have surgery or radiotherapy within 4 weeks or have temporary radiotherapy for palliative treatment within 2 weeks
  • A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction)
  • Other cancer diagnosed within past 5 years or currently suffering , but other than cure basal cell carcinoma and cervical carcinoma in situ
  • Within 12 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc
Show all 18Show fewer
  • Uncontrollable thyroid dysfunction, even using medical therapy
  • Preexisting arrhythmia (including QT interval ≥ 450ms for male and 470ms for female) and ≥ grade I heart failure
  • Patients with uncontrollable hypertension after using single agent therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg).
  • Known acute or chronic active hepatitis
  • Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
  • Less than 4 weeks from the last clinical trial
  • Child bearing or pregnancy female. Potential child bearing female must have a negative urine or serum pregnancy test result before initiating.
  • 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 drug.
  • 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.
  • Mental disorders history, or Psychotropic drug abuse history
  • Abuse of Psychiatric drugs or dysphrenia
  • Other reasons from investigators' judgement

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing Bayi Hospital

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: A Single Arm, Open Label, Multicenter, Phase II Study of Famitinib in Patients With Gastrointestinal Stromal 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 gastrointestinal stromal tumor who failed from imatinib therapy.

Being tested
Famitinib
Keywords
gastrointestinal stromal tumor, famitinib
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

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

  • FamitinibDrug

Study groups in NCT02336724
Study groupRoleWhat they receive
FamitinibExperimental25 mg qd p.o.,28 days as one cycle,treatment discontinued when disease progression determined or intolerable toxicity 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. Disease Control Rate

    Measured: 12 weeks

Secondary outcomes (4)

  1. Objective Response Rate

    Measured: 12 weeks

  2. Progression free survival

    Measured: 24 months

  3. Overall survival

    Measured: 96 months

  4. Incidence of adverse events

    Measured: 24 months

Timeline

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

  1. First posted13 Jan 2015 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2018 (estimated)
  4. Study completionJun 2019 (estimated)

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
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02336724
Sponsor's protocol ID
FMTN-II-GIST
Status last verified
Jan 2016
First submitted
8 Jan 2015
Last updated
17 Apr 2018
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 Gastrointestinal Stromal 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 18 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: status not confirmed, as of the sponsor's last update on 17 Apr 2018. 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?

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?

Disease Control 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 NCT02336724.

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 17 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in