- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02485652
Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
17. januar 2021 oppdatert av: Hanmi Pharmaceutical Company Limited
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
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).
Studieoversikt
Detaljert beskrivelse
This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).
Studietype
Intervensjonell
Registrering (Faktiske)
162
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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Cebu, Filippinene
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Kalakhang Maynila
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Makati, Kalakhang Maynila, Filippinene
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Manila
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Pasig, Manila, Filippinene
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Metro Manila
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Manila, Metro Manila, Filippinene
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Manila, Metro Manila, Filippinene
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California
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Beverly Hills, California, Forente stater
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Burbank, California, Forente stater
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Los Angeles, California, Forente stater
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Los Angeles, California, Forente stater
- Research Site 2
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Montebello, California, Forente stater
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Orange, California, Forente stater
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San Diego, California, Forente stater
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Florida
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Boca Raton, Florida, Forente stater
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Hawaii
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Honolulu, Hawaii, Forente stater
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Illinois
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Evanston, Illinois, Forente stater
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Maryland
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Bethesda, Maryland, Forente stater
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Massachusetts
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Boston, Massachusetts, Forente stater
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New Hampshire
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Lebanon, New Hampshire, Forente stater
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North Carolina
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Charlotte, North Carolina, Forente stater
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Washington
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Washington, Washington, Forente stater
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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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Cheongju-si, Korea, Republikken
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Goyang-si, Korea, Republikken
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Hwasun, Korea, Republikken
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Incheon, Korea, Republikken
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Seongnam-si, Korea, Republikken
- Research Site 2
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Seongnam-si, Korea, Republikken
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Seoul, Korea, Republikken
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Seoul, Korea, Republikken
- Research Site 2
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Seoul, Korea, Republikken
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Seoul, Korea, Republikken
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Seoul, Korea, Republikken
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Seoul, Korea, Republikken
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Seoul, Korea, Republikken
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Seoul, Korea, Republikken
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Kuala Lumpur, Malaysia
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Kuantan, Malaysia
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Kuching, Malaysia
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Penang
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George Town, Penang, Malaysia
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Barcelona, Spania
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Barcelona, Spania
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Barcelona, Spania
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Barcelona, Spania
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La Coruna, Spania
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Madrid, Spania
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Madrid, Spania
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Navarra, Spania
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San Sebastian, Spania
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Valencia, Spania
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Valencia, Spania
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Berlin, Tyskland
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Homburg, Tyskland
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Leipzig, Tyskland
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München, Tyskland
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Ulm, Tyskland
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Objective response rate (ORR)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Keunchil Park, M.D., Ph.D, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
- Hovedetterforsker: Pasi A. Jänne, M.D., Ph.D, Dana-Farber Cancer Institute, Boston, MA, USA
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
31. august 2015
Primær fullføring (Faktiske)
8. desember 2020
Studiet fullført (Faktiske)
8. desember 2020
Datoer for studieregistrering
Først innsendt
22. juni 2015
Først innsendt som oppfylte QC-kriteriene
25. juni 2015
Først lagt ut (Anslag)
30. juni 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HM-EMSI-202
- 2015-001435-21 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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Kliniske studier på HM61713
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