Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571489
Recruitment Status : Not yet recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gimatecan Drug: tegafur, gimeracil and oteracil potassium Drug: gemcitabine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571489


Contacts
Layout table for location contacts
Contact: WANG LIWEI, MD 86-021-68385559 lwwang2013@163.com

Locations
Layout table for location information
China, Shanghai
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200127
Contact: WANG LIWEI, MD    86-021-68383364      
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
Layout table for investigator information
Study Director: WANG LIWEI, MD RenJi Hospital
Publications:
Layout table for additonal information
Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT04571489    
Other Study ID Numbers: ST1481-LEES-2020-05
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lee's Pharmaceutical Limited:
Pancreatic Cancer
chemotherapy
gimatecan
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs