A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Fallopian Tube Cancer Clinical Trial

Official title:

A Phase II Study of Gimatecan in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04846842
• Other study ID #: ST1481-LEES-2020-13
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2021
• Source: Lee's Pharmaceutical Limited
• Contact: ZHOU QI
• Phone: 13708384529
• Email: qizhou9128[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer. The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design.

Description:

The study had 3 phases: screening phase, treatment phase and follow-up phase. During the treatment phase, the drug will continue to be administered until the progression of disease, complete remission , unacceptable toxicity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subjects were able to understand the informed consent, voluntarily participate in and sign the informed consent, with good compliance and cooperation with follow-up.

2. A histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer.

3. Previous systematic treatment = 2 lines, and progression in platinum based regimens or recurrence within 6 months after the end of platinum regimen. 1) Imaging progression of recurrence and progression should be clearly recorded;2) Neoadjuvant + adjuvant chemotherapy with platinum regimen = 6 cycles, and platinum regimen after recurrence / progression = 4 cycles;3) If there is progression during the treatment of platinum based regimen, the treatment cycle is not limited;4) Recurrence / progression within 6 months after the end of neoadjuvant / adjuvant therapy is considered to have received the first-line systematic treatment.

4. Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

5. =18 years old;

6. Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;

7. Estimated life expectancy >3 months;

8. The function of important organs meets the following requirements:

1. white blood cell count (WBC) = 3.0×109/L, absolute neutrophil count (ANC) = 1.5×109/L, platelets = 100×109/L, hemoglobin = 90g/L;

2. ALT, AST= 2.5×ULN; liver metastasis: ALT?AST= 5.0×ULN;

3. serum albumin = 28g/L;

4. total bilirubin = 1.5×ULN;

5. serum creatinine = 1.5×ULN, creatinine clearance rate =60 mL/min;

6. PT= 1.5×ULN;

9. The subjects had no history of allergy to camptothecin or its components;

10. Non surgical sterilization or female subjects of childbearing age need to use a medically approved contraceptive method after signing the informed consent, during the study treatment period and within 6 months after the end of the study treatment period; non surgical sterilization female subjects of childbearing age must have negative blood HCG test within 3 days before entering the study; and they must be in non lactation period.

11. Taking drugs orally;

12. The subjects had recovered and treatment will start more than 4 weeks after the end of previous surgery, chemotherapy, targeted therapy and radiotherapy.

Exclusion Criteria:

1. Subjects who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;

2. Other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan;

3. Within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment;

4. Subjects with a history of major gastrointestinal surgery (e.g., total gastrectomy, small bowel resection) or gastrointestinal dysfunction that may alter drug absorption and activity in vivo;

5. Severe cardiovascular disease, such as NYHA grade 3-4 heart failure;

6. 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;

7. A history of immunodeficiency (including a positive HIV test result);Presence of active hepatitis B , hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);

8. Pleural effusion, pericardial effusion or ascites with clinical symptoms can not be controlled by puncture drainage or other treatment;

9. Subjects with hereditary or acquired bleeding tendency (hemophilia, thrombocytopenia, etc.), interstitial pneumonia or pulmonary fibrosis, and active tuberculosis (whether or not treated) in the past year;

10. Vaccinated with live attenuated vaccine within 4 weeks;

11. Subjects had other active malignancies within 5 years before the first dose of the investigational drug gimatecan;

12. Subjects with active meningeal metastasis or uncontrollable and untreated brain metastasis.

13. Other considered unsuitable for the study.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• Gimatecan
Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Percentage of patients with objective response assessed by best overall response (BOR) and independent review committee (IRC) of either complete response(CR) or partial remission(PR) will be reported.	To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Secondary	Progression free survival (PFS)	The 2-year progression free survival of the whole group.	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.
Secondary	Disease control rate (DCR)	will be reported.	To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Secondary	Duration of Response (DoR)	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.
Secondary	Overall survival (OS)	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.