NCT03639467

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

Phase Ib / II Study of Anlotinib Combined With Gemcitabine/Cisplatin in Previous Untreated Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In the phase Ib portion, an escalated dose cohort is recruited to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of anlotinib when given in combination with gemcitabine/cisplatin. The phase II portion is designed to characterize the efficacy and safety of the combination therapy in previous untreated patients with R/M-NPC.

Conditions

• Recurrent Nasopharyngeal Carcinoma
• Metastatic Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-18
• Primary completion: 2021-08-22
• Completion: 2023-08-15
• First posted: 2018-08-21
• Last updated: 2018-09-18

Locations

1 site across 1 country: China