a study of gimatecan (st1481) in small cell lung cancer

Conditions: Small Cell Lung Cancer

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 be given every four weeks.


Eligibility criteria:
key inclusion criteria: 1. aged 18 to 75 years old of either gender; 2. a histopathological or cytological diagnosis of small cell lung cancer(sclc); 3. recurrence or progression disease after firstline platinum-containing chemotherapy and patients intolerant or unwilling to receive standard treatment; 4. measurable cancer lesion according to response evaluation criteria in solid tumors (recist) v1.1; 5. eastern cooperative oncology group(ecog) performance status score 0-1; 6. estimated life expectancy \>4 months; 7. taking drugs orally; 8. the function of important organs meets the following requirements: 1. white blood cell count (wbc) ≥ 4.0×109/l, absolute neutrophil count (anc) ≥ 1.5×109/l, platelets ≥ 100×109/l, hemoglobin ≥ 90g/l; 2. 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; 3. serum albumin ≥ 30g/l; 4. total bilirubin ≤ 1.5×uln; 5. serum creatinine ≤ 1.5×uln, creatinine clearance rate ≥60 ml/min; 6. 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: 1. patients who have been treated previously for sclc with two system chemotherapy (except for targeted therapy, immunotherapy and antiangiogenic therapy); 2. patients who have been treated previously with topotecan, irinotecan or other topoisomerase i inhibitors; 3. known or suspected allergy or hypersensitivity to the investigational drug gimatecan ingredients or their analogues; 4. other anticancer therapy including any investigational agent within 28 days prior to the first dose of the investigational drug gimatecan; 5. 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; 6. brain metastasis or meningeal metastasis (except for asymptomatic patients with lesion stable more than 28 days); 7. major surgical intervention or trauma within 28 days prior to the first dose of investigational drug administration; 8. a history of gastrointestinal disease which affects drug absorption; 9. a history of allogeneic stem cell transplantation and organ transplantation; 10. a history of interstitial lung disease or non-infectious pneumonia; 11. patients who cannot tolerate chemotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia; 12. a history of immunodeficiency (including a positive hiv test result), or other acquired or congenital immunodeficiency diseases; 13. 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); 14. 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; 15. a history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer; 16. pregnant or lactating women.

Keywords: small cell lung cancer chemotherapy gimatecan