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A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227041
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
The Affiliated Hospital of Qingdao University
Information provided by (Responsible Party):
Nailong Yang, The Affiliated Hospital of Qingdao University

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.

Condition or disease Intervention/treatment Phase
HER-2 Positive Colorectal Cancer Drug: Pyrotinib in combination with capecitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 10, 2020
Estimated Primary Completion Date : January 10, 2021
Estimated Study Completion Date : January 10, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HER2 positive metastatic colorectal cancer Drug: Pyrotinib in combination with capecitabine
Pyrotinib in combination with capecitabine
Other Name: Capecitabine




Primary Outcome Measures :
  1. Maximally Tolerated Dose (MTD) [ Time Frame: up to 36 months ]
    Evaluation of tumor burden based on RECIST criteria.

  2. Progression-free survival (PFS) [ Time Frame: up to 36 months ]
    Evaluation of tumor burden based on RECIST criteria.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 36 months ]
    Evaluation of tumor burden based on RECIST criteria.

  2. Duration Of Response (DOR) [ Time Frame: up to 36 months ]
    Evaluation of tumor burden based on RECIST criteria.

  3. Disease Control Rate (DCR) [ Time Frame: up to 36 months ]
    Evaluation of tumor burden based on RECIST criteria.

  4. Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens;
  2. Patients with HER2 positive;
  3. Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1);
  4. Life expectancy is at least 6 months
  5. ECOG score 0-1;
  6. 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:

  1. The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis;
  2. Patients who have previously been treated with anti-Her2-targeted drugs;
  3. Patients with surgical opportunity or potential for surgical treatment;
  4. 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;
  5. Patients with any severe and/or uncontrolled disease;
  6. Patients with any or present brain metastases;
  7. Women who were pregnant or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227041


Contacts
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Contact: Tao Jiang, Dr. 18661806663 jiangtao111@sina.com

Locations
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China, Shandong
Qingdao University Hospital
Qingdao, Shandong, China
Sponsors and Collaborators
Qingdao Zhixin Health Technology Co., Ltd.
The Affiliated Hospital of Qingdao University
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Responsible Party: Nailong Yang, Principal Investigator, The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT04227041    
Other Study ID Numbers: QingdaoZHT
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents