Back to resultsA Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer
Primary Purpose
HER-2 Positive Colorectal Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Pyrotinib in combination with capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for HER-2 Positive Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
- Patients with HER2 positive；
- Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
- Life expectancy is at least 6 months
- ECOG score 0-1；
- The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes or platelets)：
Exclusion Criteria:
- The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
- Patients who have previously been treated with anti-Her2-targeted drugs；
- Patients with surgical opportunity or potential for surgical treatment；
- Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
- Patients with any severe and/or uncontrolled disease;
- Patients with any or present brain metastases；
- Women who were pregnant or breast-feeding.
Sites / Locations
- Qingdao University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HER2 positive metastatic colorectal cancer
Arm Description
Outcomes
Primary Outcome Measures
Maximally Tolerated Dose (MTD)
Evaluation of tumor burden based on RECIST criteria.
Progression-free survival (PFS)
Evaluation of tumor burden based on RECIST criteria.
Secondary Outcome Measures
Objective Response Rate (ORR)
Evaluation of tumor burden based on RECIST criteria.
Duration Of Response (DOR)
Evaluation of tumor burden based on RECIST criteria.
Disease Control Rate (DCR)
Evaluation of tumor burden based on RECIST criteria.
Incidence of Treatment-Emergent Adverse Events [Safety]
Full Information
NCT ID
NCT04227041
First Posted
January 10, 2020
Last Updated
January 12, 2020
Sponsor
Qingdao Zhixin Health Technology Co., Ltd.
Collaborators
The Affiliated Hospital of Qingdao University
1. Study Identification
Unique Protocol Identification Number
NCT04227041
Brief Title
A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer
Official Title
Single-arm, Prospective, Open-label, Exploratory Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer Patients After at Least Second-line Standard Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2020 (Anticipated)
Primary Completion Date
January 10, 2021 (Anticipated)
Study Completion Date
January 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao Zhixin Health Technology Co., Ltd.
Collaborators
The Affiliated Hospital of Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER-2 Positive Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HER2 positive metastatic colorectal cancer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pyrotinib in combination with capecitabine
Other Intervention Name(s)
Capecitabine
Intervention Description
Pyrotinib in combination with capecitabine
Primary Outcome Measure Information:
Title
Maximally Tolerated Dose (MTD)
Description
Evaluation of tumor burden based on RECIST criteria.
Time Frame
up to 36 months
Title
Progression-free survival (PFS)
Description
Evaluation of tumor burden based on RECIST criteria.
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Evaluation of tumor burden based on RECIST criteria.
Time Frame
up to 36 months
Title
Duration Of Response (DOR)
Description
Evaluation of tumor burden based on RECIST criteria.
Time Frame
up to 36 months
Title
Disease Control Rate (DCR)
Description
Evaluation of tumor burden based on RECIST criteria.
Time Frame
up to 36 months
Title
Incidence of Treatment-Emergent Adverse Events [Safety]
Time Frame
up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
Patients with HER2 positive；
Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
Life expectancy is at least 6 months
ECOG score 0-1；
The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes or platelets)：
Exclusion Criteria:
The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
Patients who have previously been treated with anti-Her2-targeted drugs；
Patients with surgical opportunity or potential for surgical treatment；
Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
Patients with any severe and/or uncontrolled disease;
Patients with any or present brain metastases；
Women who were pregnant or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Jiang, Dr.
Phone
18661806663
Email
jiangtao111@sina.com
Facility Information:
Facility Name
Qingdao University Hospital
City
Qingdao
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer
We'll reach out to this number within 24 hrs