Phase I study of tamibarotene for relapse or refractory pediatric solid tumor

Phase 1

• Conditions: Relapse or refractory pediatric solid tumor

• Registration Number: JPRN-UMIN000017053
• Lead Sponsor: ational Cancer Center Hospital East Division of Pediatric Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-09
• Study Completion: 2017-04-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

1)Synchronous or asynchronous(within 5 years)other cancer except carcinoma in situ or intramucosal carcinoma 2)Active infection requires systemic therapy 3)Any abnormalities in electrocardiogram tested within 28 days, which require intervention 4)Respiratory disorder requiring oxygen supply 5)Woman during pregnancy, or impossible to discontinue breast-feeding from within 1 month prior to enrollment to 2 years after the final dose of study treatment. Woman without intent to use birth control from within 1 month prior to enrollment to 2 years after the final dose of study treatment. Man without intent to use birth control from within 1 month prior to enrollment to 2 years after the final dose of study treatment. 6)Severe psychiatric disorder 7)Patients with history of allergy to tamibalotene 8)Patients with history of treatment with tamibarotene 9)In patients having a brain tumor or metastasis to brain, a symptom with the intracranial hypertension is poor in control 10)Patients otherwise considered ineligible for enrollment in the study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity (DLT)

Secondary Outcome Measures

Name	Time	Method
1)Adverse events 2)Clinical Benefit Rate(CBR) 3)Pharmacokinetics and dose-response for tamibarotene