A Phase 2 interventional study of Apatinib and Placebo in Nasopharyngeal Neoplasms, sponsored by Sun Yat-sen University. Terminated at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
This study will enroll patients with non-metastatic nasopharyngeal carcinoma (NPC) that have residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. The purpose is to evaluate the survival in these patients treated with apatinib (YN968D1), an inhibitor of vascular endothelial growth factor receptor (phase IIa) and to compare the survival in these patients treated with apatinib versus placebo (phase IIb).
This study has two parts. In the single arm phase IIa part, we will enroll 25 patients that have residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. All patients will receive apatinib. The purpose is to evaluate the disease free-survival (DFS) in these patients treated with apatinib. In the phase IIb part, patients will be randomized to apatinib or placebo in a ratio of 1:1. The estimated sample size is 78 in phase IIb. However, the final sample size in phase IIb will be determined based on results of the phase IIa part.
242 studies on the registry are indexed under Nasopharyngeal Neoplasms; 47 are open to participants now.
This study's enrollment of 25 is below the median of 59 across 199 interventional studies indexed under Nasopharyngeal Neoplasms.
Browse Nasopharyngeal Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Exclusion Criteria:
In the phase IIb part of this trial, patients in this arm will take oral apatinib until disease progression, intolerable toxicity, death or to a maximum of 2 years.
Drug: Apatinib
In the phase IIb part of this trial, patients in this arm will take oral placebo until disease progression, intolerable toxicity, death or to a maximum of 2 years.
Drug: Placebo
Patients will take oral apatinib. The initial dose is 500 mg once daily. 28 days as one cycle. After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance. Dose interruption or reduction is permitted in case of adverse events per protocol.
Also known as: YN968D1
Patients will take oral placebo. The initial dose is 500 mg once daily. 28 days as one cycle. After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance. Dose interruption or reduction is permitted in case of adverse events per protocol.
Also known as: Placebo tablet
Disease-free survival
Time frame: 3 years
overall survival
Time frame: 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Changes in quality of life (QOL) as assessed by EORTC QLQ-C30
Time frame: 2 years
Distance Metastasis Free Survival
Time frame: 3 years
locoregional relapse free survival
Time frame: 3 years
Correlation of plasma EBV DNA load with the effect of apatinib on survival
Time frame: 3 years
Correlation of pretreatment serum VEGF level with the effect of apatinib on survival
Time frame: 3 years
Correlation of pretreatment serum VEGFR-2 level with the effect of apatinib on survival
Time frame: 3 years
Correlation of adverse event (hypertension) with the effect of apatinib on survival
Time frame: 3 years
Correlation of adverse event (hand-foot syndrome) with the effect of apatinib on survival
Time frame: 3 years
Correlation of the change from baseline in serum VEGF level at 4 weeks with the effect of apatinib on survival
Time frame: 3 years
Correlation of the change from baseline in serum VEGFR-2 level at 4 weeks with the effect of apatinib on survival
Time frame: 3 years
Plan to share: No
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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apatinib