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

Phase 1TerminatedNCT04131192

Sunshine Lake Pharma Co., Ltd.13 enrolled

Overview

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。

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Z650DRUG

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

GemcitabineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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%

Locations (2)

Jiangsu Province Hospital

Nanjing, China/jiangsu, China

shandong Cancer Hospital

Jinan, China/shandong, China

Outcomes

Primary Outcomes

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.

Time frame: 21 days

Secondary Outcomes

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

Time frame: 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

Time frame: up to approximately 24 months

Disease Control Rate (DCR)

DCR, proportion of patients with best overall response of CR, PR or stable disease (SD)

Time frame: 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

Time frame: 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

Time frame: up to approximately 24 months

Overall Survival (OS)

Data from ClinicalTrials.gov

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