NCT02691871

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

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-type Epidermal Growth Factor Receptor (EGFR)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Apatinib (250 mg/d) + Docetaxel (60 mg/m2)
DRUG	Apatinib (500 mg/d) + Docetaxel (60 mg/m2)
DRUG	Apatinib (750 mg/d) + Docetaxel (60 mg/m2)

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2016-02-25
• Last updated: 2016-02-25