Clinical Trial: Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Lung Adenocarcinoma Harboring Wild-type EGFR
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase I, Open-label, Dose-escalation Study of Apatinib in Combination With Docetaxel as 2nd Line Treatment in Patients With Advanced Lung Adenocarcinoma Harboring Wild-t
Brief Summary: 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.
Detailed Summary:
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Current Primary Outcome:
- Maximum tolerated dose (MTD) of Apatinib in combination with Docetaxel (60 mg/m2) [ Time Frame: During the first treatment course, up to 3 weeks ]
- Number of Participants Experienced Dose Limited Toxicity (DLT) in Combination Therapy of Apatinib and Docetaxel [ Time Frame: During the first treatment course, up to 3 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 for All Courses [ Time Frame: Between the first administration of Docetaxel and 28 days after last administration of Apatinib, up to 1 year ]
- Objective Response Rate (ORR) [ Time Frame: Every 6 weeks from the first treatment course, up to 1 year ]
- Progression-free Survival (PFS) [ Time Frame: Every 6 weeks from the first treatment course, up to 2 year ]
Original Secondary Outcome: Same as current
Information By: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Dates:
Date Received: February 3, 2016
Date Started: February 2016
Date Completion: December 2016
Last Updated: February 22, 2016
Last Verified: February 2016
