desmoid desmoid
Conditions
Interventions
Single group: Auranofin 3 mg 1 tablet at a time, 2 tablets daily after breakfast and after supper, orally administered for 52 weeks or until disease progression, death or unacceptable side effects.
Sponsors
Nishida Yoshihiro
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, MRI T2-weighted image evaluation, pain / QOL evaluation | — |
Contacts
Public ContactYoshihiro Nishida
Nagoya University
Outcome results
None listed