JPRN-jRCTs041210071
Recruiting
Phase 2
Specified clinical trial on the efficacy and safety of auranofin for desmoid-type fibromatosis - Auranofin clinical trial for desmoid (ACTD)
ishida Yoshihiro0 sites23 target enrollmentSeptember 16, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- desmoid
- Sponsor
- ishida Yoshihiro
- Enrollment
- 23
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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