Clinical trial NCT04846842: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: epithelial ovarian, fallopian tube or peritoneal cancer
Platinum resistant
chemotherapy
gimatecan
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2021-04-15
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 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.
measure: Disease control rate (DCR)
timeFrame: To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
measure: Duration of Response (DoR)
timeFrame: 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.
measure: Overall survival (OS)
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Chongqing Tumor Hospital
name: ZHOU QI
role: STUDY_DIRECTOR
References:
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.