Status:
UNKNOWN
A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04846842
Start Date
July 1 2021
End Date
July 1 2023
Last Update
April 19 2021
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