ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.

NCT03792568 | Unknown

• 1 other identifier: AICAM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

ALK mutation; ALK inhibitor; Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Respone Rate(ORR)

  Evaluation of tumor burden based on RECIST criteria every 2 month.

  up to 36months

Study Arms (1)

ALK mutation

EXPERIMENTAL

Other: ALK Inhibitor

Interventions

ALK Inhibitor OTHER

Any ALK inhibitor like crizotinib, alectinib and so on.

ALK mutation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (3)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

1,1'-(4,4'-(((5-chloropyrimidine-2,4-diyl)bis(azanediyl))bis(3-methoxy-4,1-phenylene))bis(piperazine-4,1-diyl))diethanone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ALK inhibitor in Metastatuc Colorectal Cancer with ALK mutation.

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 3, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2021
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)