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

NCT02364362 | Completed Phase 1

• 1 other identifier: HR-FMTN- Ⅱ-NSCLC-COM
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of famitinib in combination with standard-dose docetaxel(60 mg/m^2)

  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)

  3 weeks

Secondary Outcomes (7)

• Incidences of Adverse Events according to Common Toxicity Criteria (CTC version 4.0) associated with increasing doses of famitinib

  1 years

• Pharmacokinetics-AUC

  6 weeks

• Pharmacokinetics-Cmax

  6 weeks

• Pharmacokinetics-Tmax

  6 weeks

• Pharmacokinetics-t1/2

  6 weeks

Study Arms (1)

Famitinib + docetaxel

EXPERIMENTAL

Low, medium and high dose of famitinib and 60 mg/m\^2 docetaxel every 3 weeks

Drug: famitinib L + docetaxel; Drug: famitinib M + docetaxel; Drug: famitinib H + docetaxel

Interventions

famitinib L + docetaxel DRUG

famitinib 15mg qd + docetaxel 60 mg/m\^2

Famitinib + docetaxel

famitinib M + docetaxel DRUG

famitinib 20mg qd + docetaxel 60 mg/m\^2

Famitinib + docetaxel

famitinib H + docetaxel DRUG

famitinib 25mg qd + docetaxel 60 mg/m\^2

Famitinib + docetaxel

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 years;
• ECOG PS (Eastern Cooperative Oncology Group Performance Status)of 0 or 1;
• Life expectancy of at least 12 weeks;
• Histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC;
• Relapse or failure of one first line prior platinum-based chemotherapy;EGFR mutation type previously treated with platinum-based chemotherapy and EGFR inhibitors;
• 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;
• 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

You may not qualify if:

• More than one chemotherapy treatment regimen (except,either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) for advanced and/or metastatic or recurrent NSCLC;
• Previous therapy with other VEGFR inhibitors (including sunitinib,sorafenib,pazopanib,axitinib,other than bevacizumab) or docetaxel for treatment of NSCLC;
• Radiographical evidence of cavitary or necrotic tumours;
• Centrally located tumours with radiographical evidence (CT or MRI) of local invasion of major blood vessels;
• Pre-existing ascites and/or clinically significant pleural effusion;
• Pulmonary hemorrhage/ bleeding event ≥ CTCAE gr. 2 before initiating investigational drugs;
• History of clinically significant haemoptysis within the past 3 months（24h \>half teaspoon）;
• Current peripheral neuropathy greater than CTCAE grade 2;
• Other malignancy within the past 3 years other than basal cell skin cancer, or carcinoma in situ of the cervix;
• Active brain metastases (such as stable time ≤ 4 weeks,no radiotherapy treatment,any symptoms,or seizures treatment needing) or leptomeningeal disease.;
• 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;
• Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;
• 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.;
• 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);
• Urine protein ≥ + + and confirmed the 24-hour urinary protein\>1.0 g;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: February 18, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 18, 2019

Record last verified: 2018-12

Locations

CN (1)