Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Lung Adenocarcinoma Harboring Wild-type EGFR

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT02691871
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to confirm the safety of Apatinib at a dose level up to 750 mg/d with standard therapy of docetaxel (60 mg/m²) in advanced lung adenocarcinoma patients harboring wild-type EGFR after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.

Key Dates

Start date
Feb 29, 2016
Status verified
Feb 2016
Primary completion
Oct 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib + Docetaxel
    Low, medium or high dose of Apatinib (days 3-19, q3w) and Docetaxel (60 mg/m2, day 1, q3w)

Primary Outcome Measure

Maximum tolerated dose (MTD) of Apatinib in combination with Docetaxel (60 mg/m2) [ Time Frame: During the first treatment course, up to 3 weeks ]

Central Contacts

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