- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501029
A Study of Gimatecan (ST1481) in Small Cell Lung Cancer
August 2, 2020 updated by: Lee's Pharmaceutical Limited
A Phase Ib/II Study of Gimatecan (ST1481) for Small Cell Lung Cancer Patients Who Failed Standard Platinum-containing Chemotherapy
This phase Ib/II clinical trial studies the safety and effect of Gimatecan in small cell lung cancer patients who failed the first-line standard platinum-containing chemotherapy.
The chemotherapy will be given every four weeks.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: LIU XIAOQING, MD
- Phone Number: 86-010-66947797
- Email: liuxiaoqing@csco.org.cn
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100071
- The Fifth Medical Center of General Hospital of the Chinese People's Liberation Army
-
Contact:
- LIU XIAOQING, MD
- Phone Number: 86-010-66947797
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Aged 18 to 75 years old of either gender;
- A histopathological or cytological diagnosis of small cell lung cancer(SCLC);
- Recurrence or progression disease after firstline platinum-containing chemotherapy and patients intolerant or unwilling to receive standard treatment;
- Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
- Estimated life expectancy >4 months;
- Taking drugs orally;
The function of important organs meets the following requirements:
- white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
- ALT, AST and AKP ≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN, ALP ≤ 6.0×ULN; bone metastases ALT、AST≤ 2.5×ULN, ALP ≤ 5.0×ULN;
- serum albumin ≥ 30g/L;
- total bilirubin ≤ 1.5×ULN;
- serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min;
- INR ≤ 1.5, PT≤ 1.5×ULN;
10. Serum HCG negative in premenopausal women, female patients of childbearing potential and male patients with female partners of childbearing potential must be willing to avoid pregnancy; 11. Ability to understand the study and sign informed consent.
Key exclusion Criteria:
- Patients who have been treated previously for SCLC with two system chemotherapy (except for targeted therapy, immunotherapy and antiangiogenic therapy);
- Patients who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;
- Known or suspected allergy or hypersensitivity to the investigational drug gimatecan ingredients or their analogues;
- Other anticancer therapy including any investigational agent within 28 days prior to the first dose of the investigational drug gimatecan;
- Patients who have been treated previously with intravenous or oral drugs that affect CYP isoenzymes within 7 days prior to the first dose of the investigational drug gimatecan;
- Brain metastasis or meningeal metastasis (except for asymptomatic patients with lesion stable more than 28 days);
- Major surgical intervention or trauma within 28 days prior to the first dose of investigational drug administration;
- A history of gastrointestinal disease which affects drug absorption;
- A history of allogeneic stem cell transplantation and organ transplantation;
- A history of interstitial lung disease or non-infectious pneumonia;
- Patients who cannot tolerate chemotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;
- A history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;
- Presence of active hepatitis B (HBV DNA ≥ 200 IU/mL or 103 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
- A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
- A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
- Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limited toxicity (DLT)
Time Frame: up to 28 days.
|
Phase Ib: Number of patients experienced any dose limited toxicity over the DLT period.
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up to 28 days.
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Recommended phase II dose (RP2D)
Time Frame: up to 12 months.
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Phase Ib: Determination of recommended phase II dose of escalating dose of gimatecan for the phase II part of the study.
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up to 12 months.
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Objective response rate (ORR)
Time Frame: To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
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Percentage of patients with objective response assessed by best overall response (BOR) of either complete response(CR) or partial remission(PR) will be reported.
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To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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The 2-year progression free survival of the whole group.
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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.
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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.
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The 2-year overall survival of the whole group.
|
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.
|
Disease control rate (DCR)
Time Frame: To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
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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.
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To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
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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.
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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).
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First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months.
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Survival rate (SR)
Time Frame: up to 24 months.
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Survival probability of patients calculated according to Kaplan-Meier curve at either 1 or 2 year.
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up to 24 months.
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Treatment related adverse events rate
Time Frame: From the enrollment to 30 days later of the last chemotherapy.
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The incidence rate of treatment related adverse events of the whole group assessed by CTCAE v5.0.
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From the enrollment to 30 days later of the last chemotherapy.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: LIU XIAOQING, MD, The Fifth Medical Center of the Chinese PLA General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hurwitz JL, McCoy F, Scullin P, Fennell DA. New advances in the second-line treatment of small cell lung cancer. Oncologist. 2009 Oct;14(10):986-94. doi: 10.1634/theoncologist.2009-0026. Epub 2009 Oct 9.
- Owonikoko TK, Behera M, Chen Z, Bhimani C, Curran WJ, Khuri FR, Ramalingam SS. A systematic analysis of efficacy of second-line chemotherapy in sensitive and refractory small-cell lung cancer. J Thorac Oncol. 2012 May;7(5):866-72. doi: 10.1097/JTO.0b013e31824c7f4b.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
August 2, 2020
First Posted (Actual)
August 6, 2020
Study Record Updates
Last Update Posted (Actual)
August 6, 2020
Last Update Submitted That Met QC Criteria
August 2, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST1481-LEES-2020-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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