Status:
TERMINATED
Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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。
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04131192
Start Date
November 11 2019
End Date
September 9 2021
Last Update
May 6 2022
Active Locations (2)
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1
Jiangsu Province Hospital
Nanjing, China/jiangsu, China, 210029
2
shandong Cancer Hospital
Jinan, China/shandong, China, 250117