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

Lee's Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Treatments: Drug: Gimatecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04846842

ST1481-LEES-2020-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

46 participants in 1 patient group

Gimatecan group

Experimental group

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）).

Treatment:

Drug: Gimatecan