Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

All Drugs and Chemicals

Mitogens

Z650 will be administered daily, at dose of 350 mg orally

receive oral Z650 once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days

Z650

Jianming Xu, PHD

The purpose of this study is to evaluate the safety and efficacy of Z650 in Advanced Esophageal Squamous Cell Carcinoma patients With EGFR Over expression or Gene Amplification.

It is a multi-center , open-label, singer arm study to explore the safety and efficacy of Z650 in advanced ESCC patients who had experienced systematic chemotherapy. Approximately 45 subjects will be enrolled, each subjects will receive oral Z650, at dose of 350 mg/d, repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.

Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification

A Phase Ib, Multi-center, Open-label Study of Z650 in Advanced Esophageal Squamous Cell Carcinoma (ECSS) With Epidermal Growth Factor Receptor (EGFR) Over Expression or Gene Amplification

AEs assessment via monitoring changes in vital signs (e.g.body temperature, pulse rate, blood pressure, respiratory rate,etc.) and physical examinations(e.g.height, weight, BMI,etc.)

AEs assessment via monitoring changes in clinical laboratory parameters (e.g. levels of liver, kidney, and bone marrow function) and ECG (e.g. QTc Interval).

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

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

DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause

PFS, defined as time from date of treatment to disease progression or death due to any cause

OS, defined as time from date of treatment to death due to any cause

Sunshine Lake Pharma Co., Ltd.

Gland and Hormone Related Diseases

Symptoms and General Pathology

Pancreatic Neoplasms

Recurrence

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Gemcitabine

Antimetabolites

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

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

shu zhang

lianke liu

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。

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

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

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.

description, timing, grade (Common Terminology Criteria for Adverse Events Version 5.0 \[CTCAE v5.0\]), severity, seriousness, and relatedness

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification	NCT03888092	Esophageal Squa...	Z650	18 Years - 75 Years	Sunshine Lake Pharma Co., Ltd.
Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer	NCT04131192	Pancreatic Canc...	Z650 Gemcitabine	18 Years - 75 Years	Sunshine Lake Pharma Co., Ltd.
Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification	NCT03888092	Esophageal Squa...	Z650	18 Years - 75 Years	Sunshine Lake Pharma Co., Ltd.
Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer	NCT04131192	Pancreatic Canc...	Z650 Gemcitabine	18 Years - 75 Years	Sunshine Lake Pharma Co., Ltd.

Spots Global Cancer Trial Database for z650

Every month we try and update this database with for z650 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for z650

Every month we try and update this database with for z650 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for z650 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.