NCT03475589

Study on the Adverse Drug Reactions (ADRs) of Apatinib and Their Biomarker Correlations

A Clinical Study Investigating Adverse Drug Reactions and Their Biomarker Correlations in Stage IV Cancer Patients Following Individualized Therapy of Apatinib

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 217 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The tolerability of apatinib, an effective antiangiogenic agent, varies greatly in patients with stage IV cancer during treatment. This study will include patients with advanced (stage IV) gastric cancer, non-small-cell lung cancer (NSCLC), breast cancer or ovarian cancer, who will be administered apatinib treatment starting from 250 mg Qd and closely monitored for ADRs during the period of apatinib treatment. Meanwhile, relevant assay technologies will be used to precisely detect changes of various biomarkers in the patients treated by apatinib, with the aim of identifying biomarkers related to their prognosis and relevant complications so as to screen out the favored population, establish the drug's indication(s) and reduce relevant side effects.

Conditions

• Stage IV Cancer

Interventions

Type	Name	Description
DRUG	apatinib	Patients with advanced (stage IV) gastric cancer, non-small-cell lung cancer (NSCLC), breast cancer or ovarian cancer will be included in this study to receive apatinib treaetment starting from 250 mg Qd and closely monitored for ADRs during apatinib treatment, with dosage adjustment performed as needed to make the treatment tolerable to the patients.

Timeline

• Start date: 2018-02-26
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2018-03-23
• Last updated: 2020-05-12

Locations

1 site across 1 country: China