Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model

Metastatic Cancer Clinical Trial

— NEXT-1  

Official title:

Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model: The Master Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141152
• Other study ID #: 2013-10-017
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: December 28, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.

To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.

Description:

This study nickname is NEXT-1 trial(Next pErsonalized cancer tX with mulTi). A single-center, open label trial to analysis of genetic information in advanced cancer.

If the target is to be confirmed by molecular profile, the subgroup is going to Umbrella trial type.

defined below: NEXT 1 trial is screening and feasibility -> NEXT trial is BASKET/umbrella study screening protocol(Molecular screening prolongs survival)->NEXT-1.1(gastric cancer),NEXT-1.2(colorectal cancer),NEXT-1.3(biliary tract cancer/pancreatic cancer),NEXT-1.4(Rare cancer),NEXT-1.5(genitourinary cancer)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 895
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• pathologically confirmed metastatic malignancy

• Written informed consent

Exclusion Criteria:

• patients who do not agree with biopsy

• patients who do not have enough tissue for acquisition

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	To compare response rate (RR) (per RECIST 1.1) in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus RR in patient cohort with non-matched treatment based on molecular profiling	expected average of 3 years	No
Secondary	Progression Free Survival	To compare PFS in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus PFS in patient cohort with non-matched treatment based on molecular profiling	expected average of 3 years	No
Secondary	feasibility	To evaluate changes in the tumor's molecular profile on serial biopsies	expected average of 3 years	No
Secondary	feasibility	To establish n of 1 preclinical model for each patient whenever feasible	expected average of 3 years	No