- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378389
Study Evaluating Pyrotinib/Pyrotinib in Combination With Docetaxel in Patients With HER2+ Advanced Gastric Cancer
February 27, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase I Study of Pyrotinib In Combination With Docetaxel In Patients With HER2 Positive Advanced Gastric Cancer
Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors.
This study is designed to evaluate the safety and tolerability of Pyrotinib or Pyrotinib in combination with Docetaxel in patients with HER2 positive advanced gastric cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qing Yang, MD
- Phone Number: 157 0515 5017
- Email: yangqing@hrs.com.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Recruiting
- Beijing Cancer Hospital, Peking University
-
Contact:
- Lin Shen, M.D
- Phone Number: 010-88196391
-
Principal Investigator:
- Lin Shen, M.D
-
Beijing, Beijing, China
- Not yet recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Jing Huang
-
Beijing, Beijing, China
- Not yet recruiting
- Chinese PLA General Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- Cancer center, Sun Yet-sen University
-
Contact:
- Ruihua Xu
- Phone Number: 020-87343135
-
Principal Investigator:
- Ruihua Xu, M.D
-
-
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.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged ≥18 and ≤70 years.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- At least one measurable lesion exists.(RECIST 1.1).
- Histologically or cytologic confirmed HER2 positive advanced gastric cancer (including adenocarcinoma of esophageal-gastric junction), with clinical phase III/IV.
- No severe impairment of liver and kidney function, required laboratory values including following parameters:ANC:≥1.5x109/L, Platelet count:≥90x109/L, Hemoglobin:≥9.0 g/dL, Total bilirubin:≤1xULN, ALT and AST: ≤1.5xULN (for patients with liver metastases,ALT and AST:≤5xULN), ALP:≤2.5xULN, BUN and creatine:≤1xULN, creatine clearance rate:≥50 mL/min, LVEF:≥50%, QTcF:<450 ms (male), <470 ms (female),INR:≤1.5xULN, APTT:≤1.5xULN.
- Signed informed consent.
For subjects treated by Pyrotinib only:
- Failed or intolerable of prior therapies.
For subjects treated by Pyrotinib with Docetaxel:
- Failed or intolerable of prior therapies, no previous treatment of taxane, no previous treatment of HER2 targeted inhibitors.
Exclusion Criteria:
- Subjects with third space fluid that can not be controled by drainage or other methods.
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
- Steroid treatment for more than 50 days, or in need of long-term use of steroids.
- Less than 4 weeks from the last radiotherapy,chemotherapy,surgery,hermone treatment,target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy.
- Less than 4 weeks from the last clinical trial or adverse events of previous trials (not including alopecia or asthenia).
- Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
- Subjects who can not interrupt using of the drugs causing QT prolongation during study.
- Subjects with intracranial lesions (by MRI or CT).
- Subjects suffered from other malignancies during last 5 years, not including cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma.
- Subjects with bone or skin as the only target lesion.
- Receiving any other antitumor therapy.
- Known history of hypersensitivity to any of the components or metabolites of the investigational drugs or to Tween-80.
- Subjects with clear tendency of gastointestinal bleeding. Including the following: subjects with local active ulcer lesions and fecal occult blood (++) are excluded; subjects with less than 2 months from the last history of black stools or haematemesis are excluded; for subjects with fecal occult blood (+) and primary lesion not resected, endoscopy is required,if gastric ulcer is found and the principal investigator of the site consider possible occurence of gastointestinal bleeding, the subject should be excluded.
- Ongoing infection or peripheral neuropathy (determined by investigator).
- History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
- Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test or reluctant to take effective contraceptive measures throughout the trial period.
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. Examples include, but are not limited to,hypertension, severe diabetes, or thyroid disease.
- Alcoholism, smoking (daily ≥ 5 roots) and other bad habits.
- Known history of neurological or psychiatric disease, including epilepsy or dementia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pyrotinib/Pyrotinib with Docetaxel
Subjects would be treated with Pyrotinib (Part 1) or Pyrotinib with Docetaxel (Part 2).
A subject is only allowed to participant in one part of this trial.
|
Pyrotinib oral daily, 240 mg, 320 mg, 400 mg.... Docetaxel i.v.
once every 21 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The maximum-tolerated dose (MTD) of Pyrotinib and that of Pyrotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time Frame: 21 days
|
MTD will be defined as the maximum dose level at which no more than one subject out of three experience has a dose-limiting toxicity (DLT) upon completing one treatment cycle.
DLT was defined as the certain AEs which were observed during the first cycle (D1-D21) of treatment
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time Frame: 12 months
|
12 months
|
Tmax of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time Frame: 12 months
|
12 months
|
T1/2 of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time Frame: 12 months
|
12 months
|
AUCss of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time Frame: 12 months
|
12 months
|
R of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time Frame: 12 months
|
12 months
|
the number of participants with adverse event
Time Frame: 12 months
|
12 months
|
preliminary antitumor activity for the regimen
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
August 1, 2016
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
February 11, 2015
First Submitted That Met QC Criteria
February 27, 2015
First Posted (Estimate)
March 4, 2015
Study Record Updates
Last Update Posted (Estimate)
March 4, 2015
Last Update Submitted That Met QC Criteria
February 27, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- BLTN-Id
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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