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

April 15, 2021 updated by: Lee's Pharmaceutical Limited

A Phase II Study of Gimatecan in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • ST1481

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 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.
To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
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.
The 2-year progression free survival of the whole group.
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.
Overall survival (OS)
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.
The 2-year overall survival of the whole group.
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.
Disease control rate (DCR)
Time Frame: To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
will be reported.
To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Duration of Response (DoR)
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.
The 2-year overall survival of the whole group.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lee's Pharmaceutical Limited

Investigators

  • Study Director: ZHOU QI, Chongqing Tumor Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST1481-LEES-2020-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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