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

NCT ID: NCT04501029

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-10-01

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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gimatecan

Intervention Type: DRUG

Patients will receive gimatecan orally at the recommended dose level on day 1-5 every 4 weeks.

Interventions

Gimatecan

Patients will receive gimatecan orally at the recommended dose level on day 1-5 every 4 weeks.

Intervention Type: DRUG

Other Intervention Names

ST1481

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lee's Pharmaceutical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LIU XIAOQING, MD

Role: STUDY_DIRECTOR

The Fifth Medical Center of the Chinese PLA General Hospital

Locations

The Fifth Medical Center of General Hospital of the Chinese People's Liberation Army

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

LIU XIAOQING, MD

Role: CONTACT

liuxiaoqing@csco.org.cn

86-010-66947797

Facility Contacts

LIU XIAOQING, MD

Role: primary

86-010-66947797

References

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.

Reference Type: RESULT

PMID: 19819917 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22722788 (View on PubMed)

Other Identifiers

ST1481-LEES-2020-03

Identifier Type: -

Identifier Source: org_study_id