NCT02922777

Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.

Phase 1 Trial of Dose Escalated BGB324 in Combination With Docetaxel for Previously Treated Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to evaluate the safety of the investigational study drug, BGB324 when administered in combination with docetaxel, and to establish the maximum tolerated dose.

Detailed description

Lung cancer remains the leading cause of cancer-related deaths worldwide with an estimated incidence of 1.6 million cases resulting in 1.4 million deaths in annually. Non-small-cell lung cancer (NSCLC) represents 80-85% of cases, and adenocarcinoma is the most common histology.2 The majority of NSCLC patients present with advanced or metastatic disease that is not amenable to surgical resection. Platinum-based combination chemotherapy has reached a therapeutic plateau with a median overall survival (OS) of 7.4 to 9.9 months. BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor that is over-expressed in many metastatic solid tumors and has been identified as a marker of a poor prognosis in patients with non-small cell lung cancer (NSCLC).

Conditions

• Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	BGB324	75 mg/m2 every 21 days
DRUG	Docetaxel	75 mg/m2 given IV every 21 days

Timeline

• Start date: 2016-11-01
• Primary completion: 2023-02-06
• Completion: 2023-04-04
• First posted: 2016-10-04
• Last updated: 2024-02-21

Locations

2 sites across 1 country: United States