A Study of Famitinib Plus Docetaxel in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
NCT02364362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2019-01-18
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)
Interventions
- 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
Sponsors & Collaborators
-
Shanghai Pulmonary Hospital, Shanghai, China
collaborator OTHER -
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- China
Study Locations
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