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A Study of Gimatecan (ST1481) in Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04501029
Recruitment Status : Not yet recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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 be given every four weeks.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Gimatecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.
Drug: Gimatecan
Patients will receive gimatecan orally at the recommended dose level on day 1-5 every 4 weeks.
Other Name: ST1481




Primary Outcome Measures :
  1. Dose limited toxicity (DLT) [ Time Frame: up to 28 days. ]
    Phase Ib: Number of patients experienced any dose limited toxicity over the DLT period.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: LIU XIAOQING, MD 86-010-66947797 liuxiaoqing@csco.org.cn

Locations
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China, Beijing
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      
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
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Study Director: LIU XIAOQING, MD The Fifth Medical Center of the Chinese PLA General Hospital
Publications of Results:
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT04501029    
Other Study ID Numbers: ST1481-LEES-2020-03
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lee's Pharmaceutical Limited:
small cell lung cancer
chemotherapy
gimatecan
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms