- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02088112
MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Gefitinib in Combination With MEDI4736 (Anti PD-L1) in Subjects With Non-Small Cell Lung Cancer(NSCLC)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Seoul, Corea, Repubblica di, 05505
- Research Site
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Seoul, Corea, Repubblica di, 03080
- Research Site
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Chuo-ku, Giappone, 104-0045
- Research Site
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Matsuyama-shi, Giappone, 791-0280
- Research Site
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Florida
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Tampa, Florida, Stati Uniti, 33612
- Research Site
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Texas
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Houston, Texas, Stati Uniti, 77030
- Research Site
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Washington
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Seattle, Washington, Stati Uniti, 98109
- Research Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Key Inclusion Criteria:
- Provision of signed and dated, written informed consent
- Male or female aged 18 years and older.
- Subjects must have a. In the escalation phase, locally advanced or metastatic NSCLC subjects who have either failed to respond or relapsed following any line of standard treatment, were unable to tolerate, or were not eligible for standard treatment b. In the expansion phase, histologically or cytologically confirmed locally advanced or metastatic NSCLC that is EGFR mutation positive, naïve to EGFR TKI therapy, and sensitive to EGFR TKIs therapy
- a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- For Japan Escalation - the same as the global escalation I/E criteria except patients must be EGFR mutation positive
Key Exclusion Criteria:
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
- Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment
- Inadequate bone marrow reserve or organ function
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Escalation
MEDI4736 will be combined with gefitinib to assess safety and tolerability
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Gefitinib QD
MEDI4736 IV Q2W
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Sperimentale: Expansion Arm
MEDI4736 will be combined with gefitinib
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Gefitinib QD
MEDI4736 IV Q2W
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Escalation Phase: safety and tolerability: AEs, laboratory data, vital signs, ECG changes and Echo. Expansion Phase: safety and tolerability of the recommended dose for MEDI4736; AEs, laboratory data, vital signs, ECG changes and Echo.
Lasso di tempo: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
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AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]; Safety Labs: Blood and urine samples for determination of clinical chemistry, hematology, coagulation, thyroid function tests and urinalysis will be taken at the visits; any laboratory abnormalities, and including dose-limiting toxicities (DLTs), ECG measurements and Creatinine Clearance
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From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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To obtain a preliminary assessment of the anti-tumour activity of gefitinib in combination with MEDI4736 by evaluation of tumour response
Lasso di tempo: From baseline assessment to disease progression, assessed up to 30 months
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At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments; Objective response rate: the percentage of subjects who have at least one visit response of CR or PR prior to any evidence of progression .
Disease control rate: the percentage of subjects who have at least one visit response of CR or PR or SD prior to any evidence of progression.
Progression Free Survival (PFS) : the time from start of study treatment to the first documentation of objective disease progression (PD) or death from any cause.
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From baseline assessment to disease progression, assessed up to 30 months
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To determine the immunogenicity of MEDI4736 in combination with gefitinib: anti-drug antibodies (ADAs)
Lasso di tempo: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
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Assessed by evaluating the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
The impact of ADAs on overall MEDI4736 PK will also be evaluated.
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From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
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To determine the pharmacokinetics of MEDI4736
Lasso di tempo: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
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Individual MEDI4736 concentrations will be tabulated by dose cohort along with descriptive statistics.
Noncompartmental PK data analysis will be performed
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From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
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To assess MEDI4736 pharmacodynamics in subjects receiving MEDI4736 in combination with gefitinib.
Lasso di tempo: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
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PD-L1 levels before and after treatment with MEDI4736 will be measured to evaluate its association with response to treatment with MEDI4736 and clinical outcome
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From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
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To determine overall survival (OS) in expansion Arm 1 and Arm 1a patients
Lasso di tempo: From final safety follow-up visit after last dose until 1 year after the final patient discontinues investigational product (initial Medi4736).
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Survival information may be obtained via telephone contact with the patient, patients family or by checking the patients notes, hospital records, contacting the patients general practitioner or public death registry, where it is possible to do so under applicable local laws.
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From final safety follow-up visit after last dose until 1 year after the final patient discontinues investigational product (initial Medi4736).
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Sang-We Kim, MD, Asan Medical Center
- Investigatore principale: Laura Chow, MD, University of Washington
- Investigatore principale: Ben Creelan, MD, Moffit Cancer Center
- Investigatore principale: Don Gibbons, MD, M.D. Anderson Cancer Center
- Investigatore principale: Shinitaro Kanda, MD, National Cancer Center
- Investigatore principale: Naoyuki Nogami, Shikoku Cancer Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Agenti antineoplastici, immunologici
- Inibitori della chinasi proteica
- Durvalumab
- Gefitinib
Altri numeri di identificazione dello studio
- D791PC00001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
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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