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

NCT02356991 | Suspended Phase 2

• 1 other identifier: HR-FMTN- Ⅱ-NSCLC-MON
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 2

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).

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Keywords

Famitinib; Phase II; NSCLC

Outcome Measures

Primary Outcomes (1)

• Progress free survival (PFS)

  1.5 years

Secondary Outcomes (4)

• Overall Survival (OS)

  2 years

• Objective Response Rate (ORR)

  1 years

• Disease Control Rate (DCR)

  1 years

• Quality of Life

  28-day cycle visit until disease progress

Study Arms (2)

Famitinib

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Famitinib DRUG

Famitinib

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70;
• 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);
• 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)
• ECOG Performance Status of 0 or 1;
• Life expectancy of at least 3 months;
• 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;
• 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

You may not qualify if:

• Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (lung cancer including small cell carcinoma and non-small cell hybrid);
• Known brain metastases, spinal cord compression, cancer meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
• 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;
• Variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction);
• 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;
• Distance between tumours lesions and major blood vessels with radiographical evidence (CT or MRI) ≥5mm.
• 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;
• Long-term untreated wounds or fractures;
• 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;
• Urine protein ≥ + + and confirmed the 24-hour urinary protein\>1.0 g;
• 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;
• Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range;
• Pre-existing ascites and/or clinically significant pleural effusion;
• Active hepatitis C and/or B infection;
• Abuse of psychiatric drugs or dysphrenia;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Sun Yat-sen University: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (2)

Cancer Hospital of Guangzhou Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Tongji University Affiliated Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

famitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Zhang, M.D.

  Cancer Hospital of Guangzhou Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 6, 2015
• Study Start: December 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 4, 2019

Record last verified: 2019-10

Locations

CN (2)