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Non-Small Cell Lung Cancer (NSCLC)Phase 2NCT02356991

A Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Famitinib in people with Non-Small Cell Lung Cancer (NSCLC), run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Suspended

Paused. Enrolment is on hold for now and may 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 Non-squamous and Non-Small Cell Lung Cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Small Cell Lung Cancer (NSCLC)
What is being tested?
Famitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
137 participants
Where
2 sitesChina
Study dates
Dec 2014to Jun 2020
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Age: 18-70;
  • 2.Advanced (IV phase)non squamous NSCLC confirmed by pathology, with measurable lesions (tumour lesions ≥10mm in longest diameter, malignant lymph nodes ≥15mm in short axis, scanning layer ≤ 5 mm, measurable lesions not received locoregional theraphy ,such as radiotherapy or frozen therapy);
  • 3.Previously treated with EGFR inhibitors or chemotherapy,second line or above treatment failure:
  • a.for EGFR wild type, second line or above treatment failure(at least previously treated with platinum-based chemotherapy)
  • b.for EGFR mutation type, third line or above treatment failure(at least previously treated with Platinum-based chemotherapy and EGFR inhibitors)
  • 4.ECOG Performance Status of 0 or 1;
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  • 5.Life expectancy of at least 3 months;
  • 6.Damage caused by other anti-tumor therapy has been restored, the nitroso or mitomycin treatment interval ≥ 6 weeks; other cytotoxic drugs, radiotherapy or surgery for ≥ 4 weeks; EGFR molecular targeted drugs for ≥ 2 weeks;
  • 7.Participants have inadequate organ and marrow function as defined below:
  • Hemoglobin ≥ 90g/L ( no blood transfusion in 2 weeks)
  • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
  • PLT ≥ 80×10^9/L
  • Bilirubin < 1.25 × ULN
  • ALT < 2.5 × ULN
  • AST < 2.5 × ULN
  • serum creatinine < 1.25 × ULN, and endogenous Cr clearance > 45 ml/min(Cockcroft-Gault Formula)
  • cholesterol ≤ 1.5×ULN and triglyceride≤ 2.5 × ULN
  • LVEF≥ LLN by Color Doppler Ultrasonography
  • 8.Female: Child bearing potential, a negative urine or serum pregnancy test result 7 days before initiating famitinib.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 8 weeks after the last dose of test article. 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 8 weeks after the last dose of test article;
  • 9.Ability to understand and willingness to sign a written informed consent. Good compliance with follow-up visits.

Who cannot join

  • 1.Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (lung cancer including small cell carcinoma and non-small cell hybrid);
  • 2.Known brain metastases, spinal cord compression, cancer meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
  • 3.Patients with hypertension using combination 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 II cardiac dysfunction,according to NCI-CTC AE 4.0;
  • 4.Variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction);
  • 5.Coagulation abnormalities (PT or PT-INR > 1.5 ULN, and APTT > 1.5 ULN), bleeding tendency (eg, active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy;
  • 6.Distance between tumours lesions and major blood vessels with radiographical evidence (CT or MRI) ≥5mm.
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  • 7.Pulmonary hemorrhage/ bleeding event ≥ CTCAE gr. 1 （including Hemoptysis≥2.5ml or half teaspoon）within four weeks of the first dose of the study drug; Any other hemorrhage/ bleeding event ≥ CTCAE gr. 2 within four weeks of the first dose of the study drug;
  • 8.Long-term untreated wounds or fractures;
  • 9.Thrombotic or embolic venous or arterial events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 12 months prior to the first dose of study drug;
  • 10.Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g;
  • 11.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) ，low-dose heparin (0.6~1.2 ×10^8 U daily) low-dose aspirin (less than 100mg daily) is allowed;
  • 12.Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range;
  • 13.Pre-existing ascites and/or clinically significant pleural effusion;
  • 14.Active hepatitis C and/or B infection;
  • 15.Abuse of psychiatric drugs or dysphrenia;
  • 16.Participated in other anti-cancer clinical trials within four weeks;
  • 17.Prior therapy with VEGFR inhibitor，except Bevacizumab (Avastin);
  • 18.Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer Hospital of Guangzhou Sun Yat-sen University

    Guangzhou, Guangdong, 510060

  • Tongji University Affiliated Shanghai Pulmonary Hospital

    Shanghai, 200433

Other trials in China

About this study

Official title: A Randomized,Double-Blind, Placebo-Controlled, Multicenter, Phase II Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)

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 Non-squamous and Non-Small Cell Lung Cancer (NSCLC).

Being tested
Famitinib, Placebo
Keywords
Famitinib, Phase II, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • FamitinibDrug

  • PlaceboDrug

Study groups in NCT02356991
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
PlaceboPlacebo comparatorPlacebo 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: Placebo

What is being measured

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

  1. Progress free survival (PFS)

    Measured: 1.5 years

Secondary outcomes (4)

  1. Overall Survival (OS)

    Measured: 2 years

  2. Objective Response Rate (ORR)

    Measured: 1 years

  3. Disease Control Rate (DCR)

    Measured: 1 years

  4. Quality of Life

    Measured: 28-day cycle visit until disease progress

Timeline

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

  1. First posted6 Feb 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Why it stopped: sponsor decides to suspend this trial

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02356991
Sponsor's protocol ID
HR-FMTN- Ⅱ-NSCLC-MON
Status last verified
Oct 2019
First submitted
16 Jan 2015
Last updated
4 Nov 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 Non-Small Cell Lung Cancer (NSCLC), run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 20 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: paused, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Progress free survival (PFS) (time frame: 1.5 years). 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 NCT02356991.

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 4 Nov 2019.

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