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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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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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Toronto, Canada
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Cheongju-si, Corea, Repubblica di
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Goyang-si, Corea, Repubblica di
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Hwasun, Corea, Repubblica di
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Incheon, Corea, Repubblica di
- Research Site
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Seongnam-si, Corea, Repubblica di
- Research Site 2
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Seongnam-si, Corea, Repubblica di
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Seoul, Corea, Repubblica di
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Seoul, Corea, Repubblica di
- Research Site 2
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Seoul, Corea, Repubblica di
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Seoul, Corea, Repubblica di
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Seoul, Corea, Repubblica di
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Seoul, Corea, Repubblica di
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Seoul, Corea, Repubblica di
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Seoul, Corea, Repubblica di
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Cebu, Filippine
- Research Site
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Kalakhang Maynila
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Makati, Kalakhang Maynila, Filippine
- Research Site
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Manila
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Pasig, Manila, Filippine
- Research Site
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Metro Manila
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Manila, Metro Manila, Filippine
- Research Site 2
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Manila, Metro Manila, Filippine
- Research Site
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Berlin, Germania
- Research Site
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Homburg, Germania
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Leipzig, Germania
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München, Germania
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Ulm, Germania
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Bergamo, Italia
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Bologna, Italia
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Catania, Italia
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Milano, Italia
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Rome, Italia
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Kuala Lumpur, Malaysia
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Kuantan, Malaysia
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Kuching, Malaysia
- Research Site
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Penang
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George Town, Penang, Malaysia
- Research Site
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Barcelona, Spagna
- Research Site
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Barcelona, Spagna
- Research Site 2
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Barcelona, Spagna
- Research Site 3
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Barcelona, Spagna
- Research Site 4
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La Coruna, Spagna
- Research Site
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Madrid, Spagna
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Madrid, Spagna
- Research Site 2
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Navarra, Spagna
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San Sebastian, Spagna
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Valencia, Spagna
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Valencia, Spagna
- Research Site 2
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California
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Beverly Hills, California, Stati Uniti
- Research Site
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Burbank, California, Stati Uniti
- Research Site
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Los Angeles, California, Stati Uniti
- Research Site
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Los Angeles, California, Stati Uniti
- Research Site 2
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Montebello, California, Stati Uniti
- Research Site
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Orange, California, Stati Uniti
- Research Site
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San Diego, California, Stati Uniti
- Research Site
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Florida
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Boca Raton, Florida, Stati Uniti
- Research Site
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Hawaii
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Honolulu, Hawaii, Stati Uniti
- Research Site
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Illinois
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Evanston, Illinois, Stati Uniti
- Research Site
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Maryland
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Bethesda, Maryland, Stati Uniti
- Research Site
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Massachusetts
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Boston, Massachusetts, Stati Uniti
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti
- Research Site
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North Carolina
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Charlotte, North Carolina, Stati Uniti
- Research Site
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Washington
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Washington, Washington, Stati Uniti
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
- Research Site
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Tainan, Taiwan
- Research Site 2
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Taipei, Taiwan
- Research Site
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Taipei, Taiwan
- Research Site 2
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Objective response rate (ORR)
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Keunchil Park, M.D., Ph.D, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
- Investigatore principale: Pasi A. Jänne, M.D., Ph.D, Dana-Farber Cancer Institute, Boston, MA, USA
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- HM-EMSI-202
- 2015-001435-21 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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