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

NCT04846842 | Unknown Phase 2

• 1 other identifier: ST1481-LEES-2020-13
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

epithelial ovarian, fallopian tube or peritoneal cancer; Platinum resistant; chemotherapy; gimatecan

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  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 Outcomes (4)

• 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.

• Disease control rate (DCR)

  To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.

• 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.

• 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.

Study Arms (1)

Gimatecan group

EXPERIMENTAL

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

Interventions

Gimatecan DRUG

Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.

Also known as: ST1481

Gimatecan group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Related Publications (1)

• 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.

  PMID: 19819917 RESULT

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

ST 1481

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• ZHOU QI

  Chongqing Tumor Hospital

  STUDY DIRECTOR

Central Study Contacts

ZHOU QI

CONTACT

13708384529; qizhou9128@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: April 19, 2021

Record last verified: 2021-04