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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04727853
Other study ID # HE072-CSP-001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date June 2022

Study information

Verified date January 2021
Source CSPC Ouyi Pharmaceutical Co., Ltd.
Contact Xuekun Yao, Director
Phone +8631169085937
Email yaoxuekun@mail.ecspc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multicenter, open-label, single-arm phase 2 study of irinotecan liposome injection in patients with small cell lung cancer (SCLC) who have progressed after platinum-based first-line therapy. Subjects will receive irinotecan liposome injection until progression or unacceptable toxicity.


Description:

Patients with small cell lung cancer who have progressed after platinum-based first-line therapy will be enrolled in this study. Patients will receive irinotecan liposome injection at 70 mg/m^2 intravenously, over 90 min on Days 1 of every 14-day cycle until progression or unacceptable toxicity. Imaging assessments will be conducted every three cycles to evaluate the preliminary efficacy of irinotecan liposome injection as second-line regimen in patients with SCLC.


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Study Design


Intervention

Drug:
irinotecan liposome injection
Drug: irinotecan liposome injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
CSPC Ouyi Pharmaceutical Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Other PK parameters-Cmax Cmax of total, encapsuled and free irinotecan Cycle 1(each cycle is 14 days)
Other PK parameters-AUC AUClast, AUCinf of total, encapsuled and free irinotecan Cycle 1(each cycle is 14 days)
Other PK parameters-others tmax, tlast, t1/2 of total, encapsuled and free irinotecan Cycle 1(each cycle is 14 days)
Primary Objective Response Rate (ORR) ORR was defined as the proportion of patients who achieved partial response or complete response according to RECIST V1.1 guidelines. From date of first dose until the date of first documented progression, assessed up to 24 months
Secondary Progression-free survival (PFS) from date of the first dose to date of the first documented disease progression (PD) per RECIST v1.1 or death due to any cause, whichever occurs first. From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary Overall survival (OS) from date of the first dose to date of death from any cause From date of first dose until the date of death from any cause , assessed up to 24 months
Secondary Proportion of Patients with Symptom Improvement Patient-reported EORTC-QLQ symptom scales date of the first dose to 30 days after permanent treatment termination
Secondary Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities Incidence of AE, SAE and laboratory abnormalities date of the first dose to 30 days after permanent treatment termination
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