A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Primary Purpose
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gimatecan
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring epithelial ovarian, fallopian tube or peritoneal cancer, Platinum resistant, chemotherapy, gimatecan
Eligibility Criteria
Inclusion Criteria:
- 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.
- A histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer.
- 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.
- Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- ≥18 years old;
- Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
- Estimated life expectancy >3 months;
The function of important organs meets the following requirements:
- white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
- ALT, AST≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN;
- serum albumin ≥ 28g/L;
- total bilirubin ≤ 1.5×ULN;
- serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min;
- PT≤ 1.5×ULN;
- The subjects had no history of allergy to camptothecin or its components;
- 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.
- Taking drugs orally;
- 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:
- Subjects who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;
- Other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan;
- Within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment;
- 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;
- Severe cardiovascular disease, such as NYHA grade 3-4 heart failure;
- 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;
- 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);
- Pleural effusion, pericardial effusion or ascites with clinical symptoms can not be controlled by puncture drainage or other treatment;
- 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;
- Vaccinated with live attenuated vaccine within 4 weeks;
- Subjects had other active malignancies within 5 years before the first dose of the investigational drug gimatecan;
- Subjects with active meningeal metastasis or uncontrollable and untreated brain metastasis.
- Other considered unsuitable for the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gimatecan group
Arm Description
In Phase II study, patients will receive gimatecan at fixed dose level (0.8mg/m2/d, oral, every 4 weeks) until progressive disease (PD)、complete remission(CR)).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression free survival (PFS)
The 2-year progression free survival of the whole group.
Disease control rate (DCR)
will be reported.
Duration of Response (DoR)
The 2-year overall survival of the whole group.
Overall survival (OS)
The 2-year overall survival of the whole group.
Full Information
NCT ID
NCT04846842
First Posted
April 12, 2021
Last Updated
April 15, 2021
Sponsor
Lee's Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT04846842
Brief Title
A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Official Title
A Phase II Study of Gimatecan in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Keywords
epithelial ovarian, fallopian tube or peritoneal cancer, Platinum resistant, chemotherapy, gimatecan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gimatecan group
Arm Type
Experimental
Arm Description
In Phase II study, patients will receive gimatecan at fixed dose level (0.8mg/m2/d, oral, every 4 weeks) until progressive disease (PD)、complete remission(CR)).
Intervention Type
Drug
Intervention Name(s)
Gimatecan
Other Intervention Name(s)
ST1481
Intervention Description
Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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.
Time Frame
To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
The 2-year progression free survival of the whole group.
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.
Title
Disease control rate (DCR)
Description
will be reported.
Time Frame
To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Title
Duration of Response (DoR)
Description
The 2-year overall survival of the whole group.
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.
Title
Overall survival (OS)
Description
The 2-year overall survival of the whole group.
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
A histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer.
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.
Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
≥18 years old;
Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
Estimated life expectancy >3 months;
The function of important organs meets the following requirements:
white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
ALT, AST≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN;
serum albumin ≥ 28g/L;
total bilirubin ≤ 1.5×ULN;
serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min;
PT≤ 1.5×ULN;
The subjects had no history of allergy to camptothecin or its components;
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.
Taking drugs orally;
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:
Subjects who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;
Other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan;
Within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment;
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;
Severe cardiovascular disease, such as NYHA grade 3-4 heart failure;
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;
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);
Pleural effusion, pericardial effusion or ascites with clinical symptoms can not be controlled by puncture drainage or other treatment;
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;
Vaccinated with live attenuated vaccine within 4 weeks;
Subjects had other active malignancies within 5 years before the first dose of the investigational drug gimatecan;
Subjects with active meningeal metastasis or uncontrollable and untreated brain metastasis.
Other considered unsuitable for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZHOU QI
Phone
13708384529
Email
qizhou9128@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZHOU QI
Organizational Affiliation
Chongqing Tumor Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19819917
Citation
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.
Results Reference
result
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A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
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