Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model (NEXT-1)
28 december 2015 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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)
Studietyp
Observationell
Inskrivning (Faktisk)
895
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Seoul, Korea, Republiken av, 99999
- Samsung Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
patients with treatment-refractory malignancy
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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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.
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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.
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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.
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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.
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genitourinary cancer
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Response rate
Tidsram: expected average of 3 years
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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
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expected average of 3 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Progression Free Survival
Tidsram: expected average of 3 years
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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
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expected average of 3 years
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feasibility
Tidsram: expected average of 3 years
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To evaluate changes in the tumor's molecular profile on serial biopsies
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expected average of 3 years
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feasibility
Tidsram: expected average of 3 years
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To establish n of 1 preclinical model for each patient whenever feasible
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expected average of 3 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Won Ki Kang, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2015
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 december 2015
Studieregistreringsdatum
Först inskickad
10 februari 2014
Först inskickad som uppfyllde QC-kriterierna
14 maj 2014
Första postat (Uppskatta)
19 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 december 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 december 2015
Senast verifierad
1 december 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2013-10-017
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .