Status:
UNKNOWN
A Study of Gimatecan (ST1481) in Small Cell Lung Cancer
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04501029
Start Date
October 1 2020
End Date
October 1 2023
Last Update
August 6 2020
Active Locations (1)
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1
The Fifth Medical Center of General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, China, 100071