Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Darlinghurst, Australia
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Fitzroy, Australia
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Frankston, Australia
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Kogarah, Australia
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St Albans, Australia
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Woolloongabba, Australia
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Cebu, Filipiny
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Kalakhang Maynila
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Makati, Kalakhang Maynila, Filipiny
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Manila
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Pasig, Manila, Filipiny
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Metro Manila
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Manila, Metro Manila, Filipiny
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Manila, Metro Manila, Filipiny
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Barcelona, Hiszpania
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Barcelona, Hiszpania
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Barcelona, Hiszpania
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Barcelona, Hiszpania
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La Coruna, Hiszpania
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Madrid, Hiszpania
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Madrid, Hiszpania
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Navarra, Hiszpania
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San Sebastian, Hiszpania
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Valencia, Hiszpania
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Valencia, Hiszpania
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Toronto, Kanada
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Kuala Lumpur, Malezja
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Kuantan, Malezja
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Kuching, Malezja
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Penang
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George Town, Penang, Malezja
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Berlin, Niemcy
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Homburg, Niemcy
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Leipzig, Niemcy
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München, Niemcy
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Ulm, Niemcy
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Cheongju-si, Republika Korei
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Goyang-si, Republika Korei
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Hwasun, Republika Korei
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Incheon, Republika Korei
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Seongnam-si, Republika Korei
- Research Site 2
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Seongnam-si, Republika Korei
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Seoul, Republika Korei
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Seoul, Republika Korei
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Seoul, Republika Korei
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Seoul, Republika Korei
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Seoul, Republika Korei
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Seoul, Republika Korei
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Seoul, Republika Korei
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Seoul, Republika Korei
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California
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Beverly Hills, California, Stany Zjednoczone
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Burbank, California, Stany Zjednoczone
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Los Angeles, California, Stany Zjednoczone
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Los Angeles, California, Stany Zjednoczone
- Research Site 2
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Montebello, California, Stany Zjednoczone
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Orange, California, Stany Zjednoczone
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San Diego, California, Stany Zjednoczone
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Florida
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Boca Raton, Florida, Stany Zjednoczone
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone
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Illinois
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Evanston, Illinois, Stany Zjednoczone
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Maryland
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Bethesda, Maryland, Stany Zjednoczone
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone
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New Hampshire
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Lebanon, New Hampshire, Stany Zjednoczone
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone
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Washington
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Washington, Washington, Stany Zjednoczone
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Kaohsiung, Tajwan
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Taichung, Tajwan
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Tainan, Tajwan
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Tainan, Tajwan
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Taipei, Tajwan
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Taipei, Tajwan
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Bergamo, Włochy
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Bologna, Włochy
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Catania, Włochy
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Milano, Włochy
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Rome, Włochy
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age: at least 20 years of age
- Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
- Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
- At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
- World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
- Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
- At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
- Adequate hematological and biological function
- Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
- Male patients should be documented to be sterile or agree to use barrier contraception
- Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia
Exclusion Criteria:
- Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
- Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
- Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
- Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
- History of any other malignancy
- Clinically significant uncontrolled condition(s)
- Active or chronic pancreatitis
- Anyone with cardiac abnormalities or history
- Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
- Pregnant or breast feeding
- In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
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800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Objective response rate (ORR)
Ramy czasowe: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).
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At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1
Ramy czasowe: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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To assess clinical efficacy of HM61713 regarding disease control rate (DCR).
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At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death
Ramy czasowe: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).
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At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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Progression-free survival (PFS), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first
Ramy czasowe: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).
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At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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Overall survival (OS), defined as the time from first administration of study drug until death from any cause
Ramy czasowe: From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
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To assess clinical efficacy of HM61713 regarding Overall survival (OS).
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From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
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Time to progression (TTP), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1
Ramy czasowe: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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To assess clinical efficacy of HM61713 regarding Time to progression (TTP).
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At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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Tumor shrinkage calculated as absolute change and percentage change from baseline in sum of tumor size at each assessment using RECIST tumor response
Ramy czasowe: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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To assess clinical efficacy of HM61713 regarding tumor shrinkage.
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At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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Peak concentration (Cmax) of HM61713
Ramy czasowe: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
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To determine the pharmacokinetic (PK) profile of HM61713.
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Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
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Trough plasma concentration (Ctrough) of HM61713
Ramy czasowe: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
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To determine the pharmacokinetic (PK) profile of HM61713.
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Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
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Area under the plasma concentration time curve over the 24-hour dosing interval (AUC) of HM61713
Ramy czasowe: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
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To determine the pharmacokinetic (PK) profile of HM61713.
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Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
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Patient reported outcomes (PROs)
Ramy czasowe: At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
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To assess patient reported outcomes (PROs) of health-related quality of life (HRQoL), disease/treatment-related symptoms of lung cancer, and general health status.
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At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
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ECG/QTc (absolute values and change from baseline)
Ramy czasowe: Adverse events will be collected from baseline until 28 days after the last dose
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To evaluate the effect of HM61713 on the QT interval.
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Adverse events will be collected from baseline until 28 days after the last dose
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Incidence of reported AEs and abnormal laboratory tests (AEs will be assessed using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4).
Ramy czasowe: Adverse events will be collected from baseline until 28 days after the last dose
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To assess the safety and tolerability of HM61713.
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Adverse events will be collected from baseline until 28 days after the last dose
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QTc interval as assessed by digital ECG with central reading. The QT interval will be rate-corrected using 3 methods: QTcF, QTcB and QTcS.
Ramy czasowe: Adverse events will be collected from baseline until 28 days after the last dose
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To assess the safety and tolerability of HM61713.
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Adverse events will be collected from baseline until 28 days after the last dose
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Keunchil Park, M.D., Ph.D, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
- Główny śledczy: Pasi A. Jänne, M.D., Ph.D, Dana-Farber Cancer Institute, Boston, MA, USA
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- HM-EMSI-202
- 2015-001435-21 (Numer EudraCT)
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