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

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ClinicalTrials.gov Identifier: NCT02141152
Recruitment Status : Completed
First Posted : May 19, 2014
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

Brief 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.


Condition or disease
Metastatic Cancer

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)


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Study Type : Observational
Actual Enrollment : 895 participants
Time Perspective: Prospective
Official Title: Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model: The Master Protocol
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
fresh tissue or FFPE


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with treatment-refractory malignancy
Criteria

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

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): NCT02141152


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 99999
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Chair: Won Ki Kang, MD Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeeyun Lee, MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02141152     History of Changes
Other Study ID Numbers: 2013-10-017
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes