NCT04659733

Phase I Clinical Trial of Anlotinib in Progressive, Recurrent, and Refractory Sarcoma in Children

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Yizhuo Zhang · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to observe and evaluate the safety and effectiveness of anlotinib in children with progressive, recurrent, and refractory sarcoma. Pharmacokinetics was also detected.

Detailed description

Patients were enrolled according to the standard design of the Phase I study. Anlotinib are divided into 3 dosage levels, including 8mg, 10mg, 12mg; Oral administration of anlotinib was given, qd, D1-D14; taken on an empty stomach, Every 3 weeks is a cycle, a total of 2 cycles; Starting from the first level of anlotinib, the dose will be ramped up in sequence.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride	Anlotinib are divided into 3 dosage levels, including 8mg, 10mg, 12mg; Oral administration of anlotinib was given, qd, D1-D14; taken on an empty stomach, Every 3 weeks is a cycle, a total of 2 cycles; Starting from the first level of anlotinib, the dose will be ramped up in sequence.

Timeline

• Start date: 2020-12-30
• Primary completion: 2022-12-15
• Completion: 2022-12-30
• First posted: 2020-12-09
• Last updated: 2020-12-09