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

Pancreatic Cancer Clinical Trial

Official title:

A Phase Ib, Multi-center, Open-label Study of Z650 and Gemcitabine in Advanced Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04131192
• Other study ID #: PCD-DZ650-19-001
• Status: Terminated
• Phase: Phase 1
• Start date: November 11, 2019
• Est. completion date: September 9, 2021

Study information

• Verified date: May 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.

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。

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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
Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle ,for 4-6 cycles

Locations

Country	Name	City	State
China	shandong Cancer Hospital	Jinan	China/shandong
China	Jiangsu Province Hospital	Nanjing	China/jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of dose limiting toxicities of each subject	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.	21 days
Secondary	Adverse events related to pulse dose Z650 and gemcitabine	description, timing, grade (Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v5.0]), severity, seriousness, and relatedness	up to 4 weeks after last dose
Secondary	Overall response rate (ORR)	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	up to approximately 24 months
Secondary	Disease Control Rate (DCR)	DCR, proportion of patients with best overall response of CR, PR or stable disease (SD)	up to approximately 24 months
Secondary	Duration of Response (DOR)	DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause	up to approximately 24 months
Secondary	Progression-free Survival (PFS)	PFS, defined as time from date of treatment to disease progression or death due to any cause	up to approximately 24 months
Secondary	Overall Survival (OS)	OS, defined as time from date of treatment to death due to any cause	up to approximately 24 months