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Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib

Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib - Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027209
Enrollment
30
Registered
2018-12-27
Start date
2017-08-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal cell carcinoma

Interventions

Patients are applied Amitose-bis-glyceryl ascorbate to palmar and planter region three times or higher a day with concomitant administration of 10% urea or heparinoid-containing cream.

Sponsors

Kobe University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who give informed consent and who are 20 years of age at least 2) Patients who were diagnosed renal cell carcinoma 3) Patients who recieve sunitinib treatment including previously treatment of targeted therapy and neoadjuvant therapy 4) ECOG PS: 0-2 5) Patients who are expected to survive at least 12 weeks 6) Patients who observe the protocol compliance

Exclusion criteria

Exclusion criteria: 1) Patients in whom the underlying disease is a dermatological disease at palmar and planter region at initiation of sunitinib treatment 2) Patients who are applied external medicine not involving 10% urea and heparinoid-containing cream to palmar and planter region at initiation of sunitinib treatment 3) Patients who are not able to apply 10% urea or heparinoid-containing cream to palmar and planter region 4) Patients with HFSR of grade 1 or higher at initiation of sunitinib treatment 5) Patients with infections which needs systemic treatment 6) Patients with severe hepatic disorder 7) Patients with severe renal disorder 8) Patients who are lack of felicity

Design outcomes

Primary

MeasureTime frame
Phase I: Cutaneous abnormality including erythem, edema, papula, and vesicle Phase II: Incidence of HFSR of grade 1 of higher within 6 weeks after initiation of sunitinib treatment

Countries

Japan

Contacts

Public ContactKauhiro Yamamoto

Kobe University Hospital Pharmacy

yamakz@med.kobe-u.ac.jp078-382-6659

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026