NCT05625919

A Study of Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa)

A Phase Ⅰb/Ⅱ Multi-center Study of Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ⅰb/Ⅱ multi-center study of safety and efficacy of Sirolimus for Injection (Albumin-bound) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa).

Detailed description

This is a non-randomized, multi-center, open-label, Phase Ⅰb/Ⅱ clinical trial. For phase Ⅰb, patients must have a histologically confirmed diagnosis of advanced soft tissue sarcomas (including malignant PEComa, accounting for at least 1/2) that have failed standard treatment (disease progression or relapse or intolerance, such as chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment. The recommended phase II dose (RP2D) will be determined in phase Ⅰb. For phase Ⅱ, patients must have a histologically confirmed diagnosis of malignant PEComa that is either metastatic or locally advanced and for which surgery is not a recommended option. Phase Ⅱ will use the recommended dose and dosing regimen from Phase Ⅰb.

Conditions

• Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa)

Interventions

Type	Name	Description
DRUG	Sirolimus for Injection (Albumin Bound)	Sirolimus for injection (Albumin-bound), intravenously, once a week, 21 days per cycle (two weeks-on and one week-off)

Timeline

• Start date: 2022-11-08
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-11-23
• Last updated: 2022-11-28

Locations

1 site across 1 country: China