To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer
NCT03020823 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2023-06-05
Summary
The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous platinum based therapies.
Conditions
- Head and Neck Neoplasms
Interventions
- DRUG
-
SCB01A
intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sponsors & Collaborators
-
SynCore Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Her-Shyong Shiah, MD · Taipei Medical University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-30
- Primary Completion
- 2018-11-20
- Completion
- 2018-11-20
- FDA Drug
- Yes
Countries
- Taiwan
Study Locations
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