A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Gimatecan group 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)). |
Drug: Gimatecan
Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) [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) and independent review committee (IRC) of either complete response(CR) or partial remission(PR) will be reported.
Secondary Outcome Measures
- Progression free survival (PFS) [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.
- Disease control rate (DCR) [To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.]
will be reported.
- Duration of Response (DoR) [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.
- Overall survival (OS) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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A histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer.
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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.
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Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
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≥18 years old;
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Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
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Estimated life expectancy >3 months;
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The function of important organs meets the following requirements:
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white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
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ALT, AST≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN;
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serum albumin ≥ 28g/L;
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total bilirubin ≤ 1.5×ULN;
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serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min;
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PT≤ 1.5×ULN;
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The subjects had no history of allergy to camptothecin or its components;
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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.
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Taking drugs orally;
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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:
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Subjects who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;
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Other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan;
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Within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment;
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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;
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Severe cardiovascular disease, such as NYHA grade 3-4 heart failure;
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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;
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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);
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Pleural effusion, pericardial effusion or ascites with clinical symptoms can not be controlled by puncture drainage or other treatment;
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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;
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Vaccinated with live attenuated vaccine within 4 weeks;
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Subjects had other active malignancies within 5 years before the first dose of the investigational drug gimatecan;
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Subjects with active meningeal metastasis or uncontrollable and untreated brain metastasis.
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Other considered unsuitable for the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lee's Pharmaceutical Limited
Investigators
- Study Director: ZHOU QI, Chongqing Tumor Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ST1481-LEES-2020-13