NCT03614364

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 2 Last updated 30 December 2021

What this trial tests

Phase 2 trial testing nanoxel in Salivary Duct Carcinoma in 41 participants. Status unknown.

Timeline

20 September 2018

Primary endpoint
1 September 2022

1 August 2023

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	20 September 2018
Primary completion	1 September 2022
Estimated completion	1 August 2023
Sites	1 location across South Korea

Drugs / interventions tested

• nanoxel — full drug profile →
• herzuma (TRASTUZUMAB-PKRB) — full drug profile →

Conditions studied

• Salivary Duct Carcinoma — all drugs for Salivary Duct Carcinoma →

Sponsor

Samsung Medical Center

Who can join

20 and older, any sex, with Salivary Duct Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Response rate
  Time frame: about 24months
  according to RECIST version 1.1

Sponsor's own description

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)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Polymeric Micellar Systems-A Special Emphasis on "Smart" Drug Delivery.
   Negut I, Bita B. · · 2023 · cited 66× · PMID 36986837 · DOI 10.3390/pharmaceutics15030976
2. Toward the scale-up production of polymeric nanotherapeutics for cancer clinical trials.
   Mahmud MM, Pandey N, Winkles JA, Woodworth GF, et al · · 2024 · cited 24× · PMID 38854931 · DOI 10.1016/j.nantod.2024.102314
3. Functionalized Polymeric Micelles for Targeted Cancer Therapy: Steps from Conceptualization to Clinical Trials.
   Serras A, Faustino C, Pinheiro L. · · 2024 · cited 4× · PMID 39204392 · DOI 10.3390/pharmaceutics16081047