NCT03614364

Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma

Combination of Nanoxel and Herzuma as First-line Chemotherapy in Patients With Metastatic Salivary Duct Carcinoma : Open Label Single Arm Multicenter Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

1. Study outline This is a multicenter, single-arm, phase II trial to evaluate the efficacy and safety of nanoxel plus herzuma combination chemotherapy in patients with metastatic salivary ductal cancer. Approximately 41 patients will be enrolled. Treatment will be continued until disease progression or unacceptable toxicities. Response evaluation will be performed every 2 cycles. 2. Dosing \& Treatment schedule D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks (In case of discontinuation of nanoxel without progression, single agent herzuma can be administered until progression)

Conditions

• Salivary Duct Carcinoma

Interventions

Type	Name	Description
DRUG	nanoxel	D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks
DRUG	herzuma	D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks

Timeline

• Start date: 2018-09-20
• Primary completion: 2022-09-01
• Completion: 2023-08-01
• First posted: 2018-08-03
• Last updated: 2022-01-04

Locations

1 site across 1 country: South Korea