Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 7, 2019
Date Accepted: Jul 6, 2019
Safety and efficacy of bis-glyceryl ascorbate (Amitose DGA) to treat hand-foot skin reaction in patients with renal cell carcinoma receiving sunitinib therapy (DGA study): study protocol for a phase I/II, uncontrolled, single-arm, open-label trial
ABSTRACT
Background:
Hand-foot skin reaction (HFSR) is a serious side effect induced by multiple tyrosine kinase inhibitors (TKIs). HFSR can cause treatment interruption or decreased dosing. HFSR also markedly decreases quality of life, and is associated with the therapeutic efficacy of multiple TKI. Therefore, the management and prevention of HFSR is an important issue; however, an effective method for prevention has not been established. Specific ascorbic acid derivatives can reverse multiple TKI-induced keratinocyte growth inhibition and pathological changes in vitro.
Objective:
This study was designed to evaluate the safety of bis-glyceryl ascorbate (Amitose DGA), a novel hydrosoluble and moisturizing ascorbic acid derivative, used in patients with renal cell carcinoma (RCC) receiving sunitinib therapy, and its efficacy for treatment of sunitinib-induced HFSR.
Methods:
This is a phase I/II, single-center, uncontrolled, single-arm, open-label trial. We will recruit a total of 30 patients with RCC receiving sunitinib therapy, with a 2-week on and 1-week off schedule. The participants will apply Amitose DGA-containing cream all over both palmar and plantar surfaces within 2 treatment cycles (6 weeks) of sunitinib, in combination with a general moisturizing agent, in addition to standard-of-care processes. Safety assessments will include dermatological abnormalities, clinical laboratory tests, and incidence of adverse events. Efficacy assessments will include development of HFSR and therapeutic outcomes associated with sunitinib.
Results:
This study is an ongoing study. Recruitment to DGA study began in August 2017. The study has recruited 21 subjects. The study is currently still recruiting in Japan and scheduled to end in 2021.
Conclusions:
This is the first clinical study of Amitose DGA-containing cream in patients with RCC who are receiving sunitinib therapy. The single-center, single-arm, open-label design was selected to maximize subject exposure and increase the likelihood of achieving our study endpoints. The results will provide valuable and preliminary evidence of the effects of Amitose DGA-containing cream on HFSR. Clinical Trial: This trial was prospectively registered within the UMIN Clinical Trials Registry on 1 May, 2017 (UMIN Trial ID: UMIN000027209, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000031174).
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