Auranofin clinical trial for desmoid

JRCT ID: jRCTs041210071

Registered date:16/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: desmoid
• Date of first enrollment: 05/10/2021
• Target sample size: 23
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Response rate, MRI T2-weighted image evaluation, pain / QOL evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nishida Yoshihiro