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

Sponsor
Sun Yat-sen University
Study ID
NCT03475589
Phase
PHASE4
Status
Unknown

Conditions

  • Stage IV Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • apatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 26, 2018
Status verified
May 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
217 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: single group

Primary Outcome Measure

metastasis [ Time Frame: eight weeks ]

Central Contacts