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

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ClinicalTrials.gov Identifier: NCT02364362
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
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.

This study assessed the safety and maximum tolerated dose of continuous daily treatment with Famitinib plus docetaxel (60 mg/m^2, every 3 weeks) in patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC) to determine the recommended dose for the Phase II trial.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: famitinib L + docetaxel Drug: famitinib M + docetaxel Drug: famitinib H + docetaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel Plus Famitinib Versus Docetaxel Plus Placebo in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Famitinib + docetaxel
Low, medium and high dose of famitinib and 60 mg/m^2 docetaxel every 3 weeks
Drug: famitinib L + docetaxel
famitinib 15mg qd + docetaxel 60 mg/m^2

Drug: famitinib M + docetaxel
famitinib 20mg qd + docetaxel 60 mg/m^2

Drug: famitinib H + docetaxel
famitinib 25mg qd + docetaxel 60 mg/m^2




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of famitinib in combination with standard-dose docetaxel(60 mg/m^2) [ Time Frame: 3 weeks ]
    MTD was defined as the highest dose at which incidence of dose-limiting toxicities(DLTs) in Cyle 1 was ≤33.3%(0/3,1/6,2/6)


Secondary Outcome Measures :
  1. Incidences of Adverse Events according to Common Toxicity Criteria (CTC version 4.0) associated with increasing doses of famitinib [ Time Frame: 1 years ]
  2. Pharmacokinetics-AUC [ Time Frame: 6 weeks ]
    Area under the plasma concentration-time curve (AUC) for famitinib and docetaxel

  3. Pharmacokinetics-Cmax [ Time Frame: 6 weeks ]
    Maximum measured plasma concentration (Cmax) for famitinib and docetaxel

  4. Pharmacokinetics-Tmax [ Time Frame: 6 weeks ]
    Time from dosing to the maximum plasma concentration (Tmax) for famitinib and docetaxel

  5. Pharmacokinetics-t1/2 [ Time Frame: 6 weeks ]
    Terminal half-life (t1/2(ss)) for famitinib and docetaxel

  6. Objective Response Rate (ORR) [ Time Frame: 6 weeks ]
  7. Progress free survival (PFS) [ Time Frame: 1 years ]


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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 years;
  2. ECOG PS (Eastern Cooperative Oncology Group Performance Status)of 0 or 1;
  3. Life expectancy of at least 12 weeks;
  4. Histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC;
  5. Relapse or failure of one first line prior platinum-based chemotherapy;EGFR mutation type previously treated with platinum-based chemotherapy and EGFR inhibitors;
  6. At least one target tumour lesion that has not been irradiated within the past 3 months and that can accurately be measured ,according to RECIST 1.1;
  7. Participants have adequate 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
    • Platelets(PLT)≥ 100×10^9/L
    • Bilirubin < 1.25×ULN(Upper Limit Of Normal)
    • ALT < 2.5×ULN; ALT < 5×ULN ( If have liver metastases)
    • AST < 2.5×ULN; AST < 5×ULN ( If have liver metastases)
    • Serum creatinine < 1.25×ULN, and endogenous Cr clearance > 45 ml/min(Cockcroft-Gault Formula)
    • Cholesterol ≤ 1.5×ULN and triglyceride≤ 2.5×ULN
    • Left ventricular ejection fraction(LVEF): ≥ LLN(Lower Limit Of Normal) 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. Patient has given written informed consent.

Exclusion Criteria:

  1. More than one chemotherapy treatment regimen (except,either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) for advanced and/or metastatic or recurrent NSCLC;
  2. Previous therapy with other VEGFR inhibitors (including sunitinib,sorafenib,pazopanib,axitinib,other than bevacizumab) or docetaxel for treatment of NSCLC;
  3. Radiographical evidence of cavitary or necrotic tumours;
  4. Centrally located tumours with radiographical evidence (CT or MRI) of local invasion of major blood vessels;
  5. Pre-existing ascites and/or clinically significant pleural effusion;
  6. Pulmonary hemorrhage/ bleeding event ≥ CTCAE gr. 2 before initiating investigational drugs;
  7. History of clinically significant haemoptysis within the past 3 months(24h >half teaspoon);
  8. Current peripheral neuropathy greater than CTCAE grade 2;
  9. Other malignancy within the past 3 years other than basal cell skin cancer, or carcinoma in situ of the cervix;
  10. Active brain metastases (such as stable time ≤ 4 weeks,no radiotherapy treatment,any symptoms,or seizures treatment needing) or leptomeningeal disease.;
  11. Treatment with other investigational drugs or other anti-cancer therapy, or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial;
  12. Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;
  13. Treatment with cytotoxic drugs, radiotherapy(except extremities and brain) , immunotherapy , monoclonal antibody, or TKI inhibitor therapy within the past 4 weeks, being previous anti-cancer treatment interval ≤ 4 weeks.;
  14. Patients with hypertension using combination therapy (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg). Patients with unstable angina, myocardial ischemia or myocardial infarction in the past 6 months, congestive heart failure>NYHA II,and arrhythmia (including QTcF interval ≥ 450ms for male and 470ms for female);
  15. Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g;
  16. History of major thrombotic or clinically relevant major bleeding event in the past 6 months,and known inherited predisposition to bleeding or thrombosis;
  17. PT or APTT bias from normal range≥50%;
  18. 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 aspirin (less than 100mg daily) is allowed;
  19. Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range;
  20. Diabetes mellitus can not controlled with hypoglycemic agent;
  21. Active or chronic hepatitis C and/or B infection with liver dysfunction;
  22. History of immunodeficiency disease, concurrent acquired or congenital immunodeficiency,or history of organ transplantation;
  23. Serious infections requiring systemic antibiotic therapy;
  24. Variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction);
  25. Significant weight loss (>10 %) within the past 6 months;
  26. Pregnancy , breast feeding or child bearing potential, a positive urine or serum pregnancy test result 7 days before initiating famitinib;
  27. Active alcohol or drug abuse;
  28. Any contraindications for therapy with docetaxel;History of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80);Hypersensitivity to famitinib and/or the excipients of the trial drugs;Hypersensitivity to contrast media;
  29. Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up schedule;
  30. Patients unable to comply with the protocol;
  31. 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.

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): NCT02364362


Locations
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China
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Shanghai Pulmonary Hospital, Shanghai, China

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02364362     History of Changes
Other Study ID Numbers: HR-FMTN- Ⅱ-NSCLC-COM
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: December 2018
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
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action