NCT03422445

A Study of Apatinib Combined With Temozolomide in Patients Witn Advanced Melanoma

A Phase 2 Study of Apatinib Combined With Temozolomide in the Treatment of Advanced Melanoma Patients After Conventional Treatment Failure

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

30 patients with advanced melanoma will receive apatinib plus Temozolomide as maintenance therapy.

Detailed description

In this study, we plan to enroll 30 patients with advanced melanoma patients who have failed at least one systemic treatment regimen. The therapeutic regimen is temozolomide, 300mg,po, d1-5, apatinib, 500 mg, qd, po, d1-28, Every 28 days for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. So we plan to investigate the safety and efficacy of apatinib combined with temozolomide in the treatment of advanced melanoma patients.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib：500mg/d，qd，po，d1-28
DRUG	Temozolomide	Temozolomide：300mg/d，qd，po，d1-5

Timeline

• Start date: 2018-01-08
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2018-02-05
• Last updated: 2018-02-05

Locations

1 site across 1 country: China