JPRN-jRCTs041210071RecruitingPhase 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 enrollmentStarted: September 16, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 23
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
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
- •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
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
Investigators
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