LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma

Status Terminated

Clinical Trial Summary

The purpose of this trial is to evaluate the disease control rate of nintedanib in subjects with metastatic appendiceal cancer for whom initial fluoropyrimidine-based chemotherapy has failed. Based on previous studies, the anticancer activity of nintedanib in lung and ovarian cancer trials, along with the similarities between appendiceal and colorectal cancer and potentially ovarian cancer, warrant additional investigation for the optimal treatment of metastatic appendiceal carcinomas.

Clinical Trial Description

The primary study objective is to evaluate the disease control rate. The secondary study objectives are to evaluate safety and toxicity, objective response rate, overall and 6-month progression free survival, and overall survival. Exploratory study objectives include evaluation of serum and ascites VEGF, hypertension, and paracentesis frequency in subjects with ascites at study entry. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03287947
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Terminated
Phase	Phase 2
Start date	November 10, 2017
Completion date	October 27, 2019

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