To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Ca… (NCT03020823) | Clinical Trial Compass
TerminatedPhase 2
To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer
Stopped: withdrawal by sponsor
Taiwan10 participantsStarted 2017-04-30
Plain-language 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.
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged ≥20 years;
✓. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
✓. Histological or cytological confirmed squamous cell carcinoma of head and neck, excluding nasopharyngeal carcinoma;
✓. Subjects with unresectable, unfeasible radiotherapy, recurrent or metastatic head and neck squamous cell carcinoma, after previous treatment with platinum agent;
✓. Subjects must have at least one measurable tumor lesion as defined by RECIST version 1.1 as assessed by the investigator (local radiological image assessment) or clinically evaluable disease. Physical and neurological examinations, and radiographic studies have to be performed within 28 days of Cycle 1 Day 1;
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;
✓. Life expectancy of 12 weeks or longer;
✓. Concurrent local therapy is not allowed, but concurrent palliative radiation therapy to non-measurable sites of disease such as painful bone metastasis is permitted;
Exclusion criteria
✕. Known primary CNS malignancy or CNS involvement (except for brain metastases that have been treated and are stable and subject is off steroids);
✕. Chemotherapy, radiation therapy, major surgery or investigational agents including immune or target therapies less than 4 weeks prior to study drug treatment;
What they're measuring
1
Objective Response Rate (ORR) During Treatment Phase
Timeframe: Up to approximately 15 months (assessed continuously during treatment)