Pancreatic Cancer
Conditions
Brief summary
This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.
Detailed description
This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.This phase IB trial is Multi-center and open。
Interventions
DRUGZ650
250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal
DRUGGemcitabine
Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle ，for 4-6 cycles
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
18 ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease.
Exclusion criteria
adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound evaluation of Left ventricular ejection fraction \< 50%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of dose limiting toxicities of each subject | 21 days | Rate will be assessed through summaries of adverse events, clinical laboratory abnormalities, and changes in physical exam and vital signs. All subjects who receive a single dose of study medication will be considered evaluable for safety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | up to approximately 24 months | DCR, proportion of patients with best overall response of CR, PR or stable disease (SD) |
| Duration of Response (DOR) | up to approximately 24 months | DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause |
| Overall response rate (ORR) | up to approximately 24 months | Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST v1.1 |
| Overall Survival (OS) | up to approximately 24 months | OS, defined as time from date of treatment to death due to any cause |
| Adverse events related to pulse dose Z650 and gemcitabine | up to 4 weeks after last dose | description, timing, grade (Common Terminology Criteria for Adverse Events Version 5.0 \[CTCAE v5.0\]), severity, seriousness, and relatedness |
| Progression-free Survival (PFS) | up to approximately 24 months | PFS, defined as time from date of treatment to disease progression or death due to any cause |
Countries
China
Outcome results
None listed