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

Study Overview
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Brief Summary
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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
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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。

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Z650
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: z650 and Gemcitabine<br>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<br>* 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<br>* Other names: larotinib;Drug: Gemcitabine<br>* Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle ，for 4-6 cycles<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 |