Auranofin clinical trial for desmoid
- Conditions
- desmoidD018222
- Registration Number
- JPRN-jRCTs041210071
- Lead Sponsor
- ishida Yoshihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 23
Pathologically diagnosed with desmoid
Aged 18 years or older at the time of consent
With evaluable lesions (tumors)
With tumor progression within 6 months prior to the start of the trial, or patients who are inoperable
Written consent has been obtained by the person (and the surrogate)
With ECOG PS of 0 or 1 on observation within 14 days prior to enrollment
Test results within 14 days before enrollment meet the following criteria and have sufficient organ function
White blood cell count more than 3,000 / mm3
Number of neutrophils more than 1,500 / mm3
Hemoglobin more than 9.0 g / dL
Platelet count more than 10 x 104 / mm3
Total bilirubin less than 1.5 mg / dL
AST less than l00 U / L
ALT less than 100 U / L
Creatinine clearance more than 50 mL / min
Serum creatinine less than 1.3 mg / dL
Proper cardiac function and a 12-lead ECG with normal waveform
Patients contraindicated in the auranofin package insert
Patients comparable to important basic precautions in the auranofin package insert
Patients taking auranofin within 4 weeks prior to consent
Patients who took anti-cancer drugs or targeted therapies within 4 weeks before obtaining consent
Patients who are judged by the investigator to be ineligible for enrollment in the clinical trial
Patients who are unsuitable for MRI, CT, etc.
Patients who have difficulty taking oral medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Response rate, MRI T2-weighted image evaluation, pain / QOL evaluation