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NCT Number: NCT02141152

Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model

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.

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Key information

Conditions

Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 99999, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response rate

    Time frame: expected average of 3 years

    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

Secondary outcomes

  1. Progression Free Survival

    Time frame: expected average of 3 years

    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

  2. feasibility

    Time frame: expected average of 3 years

    To evaluate changes in the tumor's molecular profile on serial biopsies

  3. feasibility

    Time frame: expected average of 3 years

    To establish n of 1 preclinical model for each patient whenever feasible

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: NEXT-1

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 19, 2014
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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