Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model (NEXT-1)

December 28, 2015 updated by: Jeeyun Lee, Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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)

Study Type

Observational

Enrollment (Actual)

895

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with treatment-refractory malignancy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
gastric cancer
This study will recruit a total of 130 gastric cancer patients. It is expected to recruit about 250 gastric cancer patients per year. Since the incidence of each mutation is low, the different types of mutations are assumed to be mutually exclusive. So, about 30% of these patients are expected to have a mutation with a target drug. Overall response (OR) is the primary endpoint of this study. OR rate (ORR) will be compared between the group (called targeted group) of patients who have a mutation with a target drug and that (called untargeted group) of patients who have no mutation. The ORR is expected to be about 25% for the targeted group and about 5% for the untargeted group. With N=130 gastric cancer patients, about 39 patients will belong to the targeted group and about 91 will belong to the untargeted group. The chi-square test with a 2-sided alpha=5% has 89% of power. The study on gastric cancer will take 7 months for patient accrual.
colorectal cancer
This study will recruit a total of 130 colorectal cancer patients. It is expected to recruit about 300 colorectal cancer patients per year. About 25% of these patients are expected to have a mutation with a target drug. ORR will be compared between the targeted group and the untargeted group. The median ORR is expected to be about 25% for the targeted group and about 5% for the untargeted group. With N=130 colorectal cancer patients, about 33 patients will belong to the targeted group and about 97 will belong to the untargeted group. The chi-square test with a 2-sided alpha=5% has 87% of power. The study on colorectal cancer will take about 6 months for accrual.
biliary tract cancer/pancreatic cancer
This study will recruit a total of 78 biliary tract cancer/pancreatic cancer patients. It is expected to recruit about 100 biliary tract cancer/pancreatic cancer patients per year. About 20% of these patients are expected to have a mutation with a target drug. ORR will be compared between the targeted group and the untargeted group. The ORR is expected to be about 35% for the targeted group and about 5% for the untargeted group. With N=78 biliary tract cancer/pancreatic cancer patients, about 16 patients will belong to the targeted group and about 62 will belong to the untargeted group. The chi-square test with a 2-sided alpha=5% has 87% of power. The study on biliary tract cancer/pancreatic cancer will take about 7 months for accrual.
Rare cancer
Rare cancer is hepatocellular carcinoma, melanoma and neuroendocrine tumor. This study will recruit a total of 87 hepatocellular carcinoma/rare cancer patients. It is expected to recruit about 150 biliary tract cancer/pancreatic cancer patients per year. About 25% of these patients are expected to have a mutation with a target drug. ORR will be compared between the targeted group and the untargeted group. The ORR is expected to be about 30% for the targeted group and about 5% for the untargeted group. With N=87 biliary tract cancer/pancreatic cancer patients, about 22 patients will belong to the targeted group and about 65 will belong to the untargeted group. The chi-square test with a 2-sided alpha=5% has 86% of power. The study on biliary tract cancer/pancreatic cancer will take about 7 months for accrual.
genitourinary cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
expected average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
expected average of 3 years
feasibility
Time Frame: expected average of 3 years
To evaluate changes in the tumor's molecular profile on serial biopsies
expected average of 3 years
feasibility
Time Frame: expected average of 3 years
To establish n of 1 preclinical model for each patient whenever feasible
expected average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Study Chair: Won Ki Kang, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-10-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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