A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer

September 29, 2020 updated by: Lee's Pharmaceutical Limited

Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study

This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
          • WANG LIWEI, MD
          • Phone Number: 86-021-68383364

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key inclusion Criteria:

  1. Histologically or cytologically confirmed pancreatic cancer originating from pancreatic ductal epithelium, excluding pancreatic endocrine tumor;
  2. Locally advanced or metastatic pancreatic cancer in no condition for radical radiotherapy or operation;
  3. Failed in first-line gemcitabine or fluorouracil drugs chemotherapy (Recurrence within 6 months after treatment, progression or toxicity intolerance during treatment);
  4. Chemotherapy, targeted therapy or radical radiotherapy should be stopped 3 weeks ago, immunotherapy should be stopped 4 weeks ago, and previous toxicity recovered (CTCAE ≤ level 1);
  5. Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
  6. No younger than 18 years old of either gender;
  7. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
  8. Estimated life expectancy >3 months;

  9. The function of important organs meets the following requirements:

    1. absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 85×109/L, hemoglobin ≥ 90g/L;
    2. serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min, U-pro < 2+ or 1.0g/L; if U-pro ≥2+ or 1.0g/L, 24 hours U-pro ≤ 1.0g/L can be included;
    3. total bilirubin ≤ 1.5×ULN, obstructive jaundice with biliary drainage: total bilirubin ≤ 2.0×ULN; alanine transaminase and aspartate aminotransferase ≤ 2.5×ULN, liver metastasis ≤ 5.0×ULN; serum albumin ≥ 30g/L;
  10. Without a history of allergy or hypersensitivity to camptothecin drugs;
  11. Taking drugs orally;
  12. Serum human chorionic gonadotropin negative in premenopausal women; female patients of childbearing potential and male patients with female partners of childbearing potential must be willing to avoid pregnancy;
  13. Ability to understand the study and sign informed consent.

Key exclusion Criteria:

  1. Patients who have been previously treated with camptothecin drugs or topoisomerase I inhibitor within 6 months before enrollment;
  2. Patients who have been previously treated with gemcitabine and fluorouracil in first-line treatment within 6 months before enrollment;
  3. Patients who have been previously treated with other investigational drugs within 4 weeks before enrollment;
  4. Patients with brain or meningeal metastasis;
  5. Patients with a history of gastrointestinal disease which affects drug absorption;
  6. Patients with serous cavity effusion with clinical symptoms (such as pleural effusion, peritoneal effusion, pericardial effusion, etc.), which continue to increase after two-week conservative treatment (excluding puncture drainage);
  7. Patients with hypertension that cannot be controlled by drugs (≥ 160/100mmhg); angina pectoris within 3 months before enrollment or unstable angina pectoris; myocardial infarction within 1 year before enrollment and cardiac insufficiency (NYHA ≥ II);
  8. Patients with active infections requiring systemic treatment or pyrexia of unknown origin prior to initial administration (except neoplastic fever);
  9. Patients with hepatitis B surface antigen positive and peripheral blood hepatitis B virus DNA ≥1.0×103 copy/mL; positive of hepatitis C antibody and peripheral blood hepatitis C virus RNA;
  10. Patients with active pulmonary tuberculosis or uncontrolled pulmonary tuberculosis after anti-tuberculosis treatment;
  11. Patients with a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;
  12. Patients with a history of malignancies other than pancreatic cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or malignant tumors that have been cured for 5 years;
  13. Pregnant or lactating women;
  14. Patients with a history of mental diseases (including epilepsy or dementia).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gimatecan group
All patients will receive gimatecan (0.8mg/m2, on days 1 to 5, PO, every 4 weeks) until progressive disease (PD).
Drug: Gimatecan
Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks.
Other Names:
  • ST1481
Placebo Comparator: placebo group
All patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD).
Drug: tegafur, gimeracil and oteracil potassium
Patients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks.
Drug: gemcitabine
Patients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks.

What is the study measuring?

Primary 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Objective response rate (ORR)
Time Frame: To evaluate objective response rate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Percentage of patients with objective response assessed by best overall.
To evaluate objective response rate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Duration of Response (DoR)
Time Frame: First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months.
The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).
First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months.
Disease control rate (DCR)
Time Frame: To evaluate disease control rate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Percentage of patients with disease control as assessed by best overall.
To evaluate disease control rate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Patient-reported outcome (PRO)
Time Frame: To evaluate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Change from baseline assessed according to the quality of life questionnaire C30.
To evaluate every 6 weeks after the initiation of chemotherapy, 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: WANG LIWEI, MD, Renji 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)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST1481-LEES-2020-05

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.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Gimatecan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe