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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gimatecan group

All patients will receive gimatecan (0.8mg/m2, on days 1 to 5, PO, every 4 weeks) until progressive disease (PD).

Group Type EXPERIMENTAL

Gimatecan

Intervention Type DRUG

Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks.

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).

Group Type PLACEBO_COMPARATOR

tegafur, gimeracil and oteracil potassium

Intervention Type DRUG

Patients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks.

gemcitabine

Intervention Type DRUG

Patients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks.

Interventions

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Gimatecan

Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks.

Intervention Type 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.

Intervention Type DRUG

gemcitabine

Patients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks.

Intervention Type DRUG

Other Intervention Names

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ST1481

Eligibility Criteria

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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.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No