NCT03614364

Brief Summary

  1. 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. 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

4 years

First QC Date

July 30, 2018

Last Update Submit

December 30, 2021

Conditions

Salivary Duct Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

    according to RECIST version 1.1

    about 24months

Study Arms (1)

nanoxel and herzuma

EXPERIMENTAL

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: nanoxelDrug: herzuma

Interventions

nanoxelDRUG

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

nanoxel and herzuma
herzumaDRUG

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

nanoxel and herzuma

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically-confirmed HER2 positive (immunohistochemistry \[IHC\] 3+, and/or fluorescence in situ hybridization\[FISH\] positive with ≥ two-fold amplification) salivary duct carcinoma(SDC), and other salivary gland carcinomas which are similar to SDC in histopathological findings, including adenocarcinoma, not otherwise specified, acinic cell carcinoma, squamous cell carcinoma, anaplastic carcinoma, high grade mucoepidermoid carcinoma, and carcinoma ex pleomorphic adenoma
  • stage IV or recurrent cancer
  • age ≥ 20 years
  • ECOG performance status 0-2
  • At least one measurable tumor lesion according to RECIST 1.1
  • Expected survival for approximately 12 weeks or longer
  • No prior systemic chemotherapy
  • At least 4 weeks later after surgery or radiotherapy
  • Written informed consent

You may not qualify if:

  • Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months(congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
  • Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
  • Pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
  • Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed)
  • Patients with alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Location

Study Officials

  • Myung-Ju Ahn, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 3, 2018

Study Start

September 20, 2018

Primary Completion

September 1, 2022

Study Completion

August 1, 2023

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations

KR(1)