A Study of Gimatecan (ST1481) in Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04501029|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Gimatecan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of Gimatecan (ST1481) for Small Cell Lung Cancer Patients Who Failed Standard Platinum-containing Chemotherapy|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 1, 2023|
Experimental: Gimatecan group
In Phase Ib study, patients will receive gimatecan at different dose level (0.4mg/m2, 0.6mg/m2,0.8mg/m2, oral, every 4 weeks) until progressive disease (PD).In Phase II study, patients will receive gimatecan at recommended phase II dose level.
Patients will receive gimatecan orally at the recommended dose level on day 1-5 every 4 weeks.
Other Name: ST1481
- Dose limited toxicity (DLT) [ Time Frame: up to 28 days. ]Phase Ib: Number of patients experienced any dose limited toxicity over the DLT period.
- Recommended phase II dose (RP2D) [ Time Frame: up to 12 months. ]Phase Ib: Determination of recommended phase II dose of escalating dose of gimatecan for the phase II part of the study.
- Objective response rate (ORR) [ Time Frame: To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months. ]Percentage of patients with objective response assessed by best overall response (BOR) of either complete response(CR) or partial remission(PR) will be reported.
- Progression free survival (PFS) [ Time Frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months. ]The 2-year progression free survival of the whole group.
- Disease control rate (DCR) [ Time Frame: To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months. ]Percentage of patients with disease control as assessed by best overall response (BOR) of either complete response(CR), partial remission(PR) or stable disease (SD) will be reported.
- Duration of Response (DoR) [ Time Frame: First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months. ]The DoR applies only to patients whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).
- Overall survival (OS) [ Time Frame: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months. ]The 2-year overall survival of the whole group.
- Survival rate (SR) [ Time Frame: up to 24 months. ]Survival probability of patients calculated according to Kaplan-Meier curve at either 1 or 2 year.
- Treatment related adverse events rate [ Time Frame: From the enrollment to 30 days later of the last chemotherapy. ]The incidence rate of treatment related adverse events of the whole group assessed by CTCAE v5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501029
|Contact: LIU XIAOQING, MDfirstname.lastname@example.org|
|The Fifth Medical Center of General Hospital of the Chinese People's Liberation Army|
|Beijing, Beijing, China, 100071|
|Contact: LIU XIAOQING, MD 86-010-66947797|
|Study Director:||LIU XIAOQING, MD||The Fifth Medical Center of the Chinese PLA General Hospital|