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Study of Anlotinib Combined With Gemcitabine/Cisplatin in Advanced Nasopharyngeal Carcinoma

NCT03639467 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-09-18

No results posted yet for this study

Summary

Gemcitabine plus cisplatin (GC) is more effective than fluorouracil plus cisplatin in the treatment of recurrent or metastatic NPC (R/M-NPC). GC is the standard first-line chemotherapy regimen for this population. However, the median progression-free survival was only 7 months for GC regimen. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis. This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus GC as first-line treatment for R/M-NPC.

Conditions

  • Recurrent Nasopharyngeal Carcinoma
  • Metastatic Nasopharyngeal Carcinoma

Interventions

DRUG

Anlotinib plus gemcitabine/cisplatin

In the phase Ib portion, patients received dose escalation of anlotinb (from 8mg to 12mg orally once daily on days 1-14 of a 21-day) in combination with fixed dose of gemcitabine (1000mg/m2 intravenously on days 1 and 8) and cisplatin (80mg/m2 intravenously on day 1) every 3 weeks. In the phase II portion, patients received anlotinb at recommended phase II dose determined in the phase Ib portion, in combination with fixed dose of gemcitabine and cisplatin every 3 weeks. The combination of anlotinib plus gemcitabine / cisplatin was repeated every 3 weeks for up to six cycles. Patients with disease control (defined as a complete response, a partial response, or stable disease) continue to receive anlotinb until disease progression or unacceptable toxic effects, whichever occurred first.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Yuankai Shi, MD · ChineseAMS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2021-08-22
Completion
2023-08-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639467 on ClinicalTrials.gov