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ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.

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ClinicalTrials.gov Identifier: NCT03792568
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Zhan Wang, Shanghai Changzheng Hospital

Brief Summary:
This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: ALK Inhibitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALK mutation Other: ALK Inhibitor
Any ALK inhibitor like crizotinib, alectinib and so on.




Primary Outcome Measures :
  1. Objective Respone Rate(ORR) [ Time Frame: up to 36months ]
    Evaluation of tumor burden based on RECIST criteria every 2 month.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;

Exclusion Criteria:

Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.


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): NCT03792568


Locations
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China, Shanghai
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Yuan-sheng Zang, Prof.    +8613816584620    doctorzangys@163.com   
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Zhan Wang, Prof.    +8613916229609    profoundamir@139.com   
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Wei-ping Dai    +8618801790929    18801790929@139.com   
Sponsors and Collaborators
Shanghai Changzheng Hospital

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Responsible Party: Zhan Wang, ALK inhibitor in Metastatuc Colorectal Cancer with ALK mutation., Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT03792568     History of Changes
Other Study ID Numbers: AICAM
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhan Wang, Shanghai Changzheng Hospital:
ALK mutation
ALK inhibitor
Metastatic Colorectal Cancer
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