Gemcitabine And Z650 In Treating Patients With Metastatic Or Recurrent Pancreatic Cancer

Study Overview

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

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 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。

Pancreatic Cancer

DRUG: Z650
DRUG: Gemcitabine

PCD-DZ650-19-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-10-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-05-04
First Submitted that Met QC Criteria 2019-10-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-05-06
First Posted (ACTUAL) 2019-10-18	Results First Posted N/A	Last Verified 2022-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: z650 and 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	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 DRUG: Gemcitabine Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle ，for 4-6 cycles

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: z650 and 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

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

DRUG: Gemcitabine

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

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: shu zhang, Shandong Cancer Hospital and Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record