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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02356991
Recruitment Status : Active, not recruiting
First Posted : February 6, 2015
Last Update Posted : January 18, 2019
Sponsor:
Collaborators:
Sun Yat-sen University
Shanghai Pulmonary Hospital, Shanghai, China
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: Famitinib Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Actual Study Start Date : December 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Famitinib
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
Placebo Comparator: Placebo
Placebo 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: Placebo



Primary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 2 years ]
  2. Objective Response Rate (ORR) [ Time Frame: 1 years ]
  3. Disease Control Rate (DCR) [ Time Frame: 1 years ]
  4. Quality of Life [ Time Frame: 28-day cycle visit until disease progress ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356991


Locations
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China, Guangdong
Cancer Hospital of Guangzhou Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
China
Tongji University Affiliated Shanghai Pulmonary Hospital
Shanghai, China, 200433
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-sen University
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: Li Zhang, M.D. Cancer Hospital of Guangzhou Sun Yat-sen University

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02356991     History of Changes
Other Study ID Numbers: HR-FMTN- Ⅱ-NSCLC-MON
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: December 2018

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Famitinib
Phase II
NSCLC

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms