Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

Phase 1

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: Z650; Drug: Gemcitabine

• Registration Number: NCT04131192
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

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。

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2019-11-11
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
z650 and Gemcitabine	Z650	Z650:250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal Gemcitabine: intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle FOR the 4-6 cycles
z650 and Gemcitabine	Gemcitabine	Z650:250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal Gemcitabine: intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle FOR the 4-6 cycles

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Disease Control Rate (DCR)	up to approximately 24 months	DCR, proportion of patients with best overall response of CR, PR or stable disease (SD)
Overall Survival (OS)	up to approximately 24 months	OS, defined as time from date of treatment to death due to any cause
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
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

Trial Locations

Locations (2)

Jiangsu Province Hospital; 🇨🇳 Nanjing, China/jiangsu, China

shandong Cancer Hospital; 🇨🇳 Jinan, China/shandong, China