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- Klinische proef 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)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Chuo-ku, Japan, 104-0045
- Research Site
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Matsuyama-shi, Japan, 791-0280
- Research Site
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Seoul, Korea, republiek van, 05505
- Research Site
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Seoul, Korea, republiek van, 03080
- Research Site
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Florida
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Tampa, Florida, Verenigde Staten, 33612
- Research Site
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Research Site
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Washington
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Seattle, Washington, Verenigde Staten, 98109
- Research Site
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: Expansion Arm
MEDI4736 will be combined with gefitinib
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Gefitinib QD
MEDI4736 IV Q2W
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Sang-We Kim, MD, Asan Medical Center
- Hoofdonderzoeker: Laura Chow, MD, University of Washington
- Hoofdonderzoeker: Ben Creelan, MD, Moffit Cancer Center
- Hoofdonderzoeker: Don Gibbons, MD, M.D. Anderson Cancer Center
- Hoofdonderzoeker: Shinitaro Kanda, MD, National Cancer Center
- Hoofdonderzoeker: Naoyuki Nogami, Shikoku Cancer Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Antineoplastische middelen, immunologisch
- Proteïnekinaseremmers
- Durvalumab
- Gefitinib
Andere studie-ID-nummers
- D791PC00001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Anhui Medical UniversityOnbekendZelfeffectiviteit | Toxiciteit van medicijnenChina
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Kunming Medical UniversityBeëindigdNiet-kleincellige longkankerChina
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NCIC Clinical Trials GroupVoltooid
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)VoltooidSlokdarmkankerVerenigde Staten