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- Klinische proef NCT02447380
Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Advanced Gastric Adenocarcinoma Patients With MET Overexpression as a Second-line Treatment
SAMSUNG MEDICAL CENTER
Phase II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in advanced gastric adenocarcinoma patients with MET overexpression as a second-line treatment.
Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor.
Subjects will receive Volitinib once daily (at the MTD determined from Phase Ib) for 21 days as one cycle.
Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.
To investigate the efficacy of volitinib when given in combination with docetaxel in patients with advanced gastric adenocarcinoma harboring MET overexpression.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Seoul, Korea, Republic Of
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Seoul, Seoul, Korea, Republic Of, Korea, republiek van, 135-710
- Samsung Medical Center
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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
Inclusion Criteria:
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after first-line therapy.
- The 1st line regimen must have contained doublet 5-fluoropyrimidine and platinum based regimen.
- Relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing doublet 5-fluoropyrimidine and platinum-based regimen could be considered as 1st line therapy.
- Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy.
- Provision or availability of biopsy sample for analysis; e.g mandatory pre-treatment biopsy, or available diagnostic biopsy of sufficient quantity/quality
- Patients with MET overexpression
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- ECOG performance status 0-1.
- Patients must have a life expectancy ≥ 3 months from proposed first dose date.
Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
- Haemoglobin ≥9.0 g/dL (transfusion allowed)
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- White blood cells (WBC) > 3 x 109/L
- Platelet count ≥100 x 109/L (transfusion allowed)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (does not include patients with Glibert's disease)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
- Serum creatinine ≤1.5 x institutional ULN
- At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
- Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. for women of childbearing potential.
- Provision of consent for mandatory biopsy at progression
Exclusion Criteria:
- More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting.
- Any previous treatment with MET inhibitors
- Any previous treatment with docetaxel.
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
- HER2 positive patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)
- Patients unable to swallow orally administered medication.
- Treatment with any investigational product during the last 28 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
- With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
- Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
- Resting ECG with measurable QTcB > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- Patients with cardiac problem as follows: uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy) Baseline Left ventricular ejection fraction below the LLN of <55% measured by echocardiography or institution's LLN for MUGA, Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest , Symptomatic heart failure (NYHA grade II-IV), Prior or current cardiomyopathy, Severe valvular heart disease, Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy), Acute coronary syndrome within 6 months prior to starting treatment
- Female patients who are breast-feeding or child-bearing and Male or female patients of reproductive potential who are not employing an effective method of contraception
- Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- Patients currently receiving (or unable to stop use at least 2 weeks) prior to receiving the first dose of AZD6094, medications known to be potent inhibitors of CYP1A2 or CYP3A4, potent inducers of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: AZD6094 (Volitinib) in combination with docetaxel
Subjects will receive Volitinib once daily (at the MTD determined from Phase Ib) for 21 days as one cycle. Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks. |
AZD6094 600MG qd
Andere namen:
Docetaxel 60 mg/m2
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Objective response rate (ORR) by RECIST 1.1
Tijdsspanne: expected average of 24 weeks
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expected average of 24 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Duur van de reactie
Tijdsspanne: verwacht gemiddeld 24 weken
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verwacht gemiddeld 24 weken
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Ziektebestrijdingspercentage
Tijdsspanne: 8 weken
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8 weken
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Algehele overleving (OS)
Tijdsspanne: verwacht gemiddeld 24 weken
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verwacht gemiddeld 24 weken
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progressievrije overleving (PFS)
Tijdsspanne: verwacht gemiddeld 24 weken
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verwacht gemiddeld 24 weken
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Number of subjects with Adverse Events as a Measure of safety and Tolerability
Tijdsspanne: expected average of 24 weeks
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expected average of 24 weeks
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Biomarker analysis
Tijdsspanne: 3years
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To see correlation between MetEx14, MET overexpression and to treatment response
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3years
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Medewerkers en onderzoekers
Sponsor
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
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2014-07-168
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op AZD6094
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Samsung Medical CenterVoltooidGeavanceerd Maag AdenocarcinoomKorea, republiek van
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AstraZenecaSCRI Development Innovations, LLCVoltooidPapillaire niercelkankerVerenigde Staten, Canada, Verenigd Koninkrijk, Spanje
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National Cancer Institute (NCI)BeëindigdColorectaal carcinoom | Gemetastaseerd colonadenocarcinoom | Gemetastaseerd rectaal adenocarcinoom | Stadium III darmkanker AJCC v8 | Stadium III Rectale kanker AJCC v8 | Stadium IIIA Darmkanker AJCC v8 | Stadium IIIA Rectale kanker AJCC v8 | Stadium IIIB Darmkanker AJCC v8 | Stadium IIIB Rectale kanker... en andere voorwaardenVerenigde Staten
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AstraZenecaQuotient SciencesVoltooidKankerVerenigd Koninkrijk
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Hutchison Medipharma LimitedVoltooid
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Jeeyun LeeWervingMaagkanker, AdenocarcinoomKorea, republiek van
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Queen Mary University of LondonAstraZeneca; Vall d'Hebron Institute of OncologyActief, niet wervendHeldercellig niercarcinoom | NierpapilcelcarcinoomVerenigd Koninkrijk
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AstraZenecaActief, niet wervendGeavanceerde niet-kleincellige longkankerCanada, Polen, Taiwan, Verenigde Staten, Korea, republiek van, Japan, Russische Federatie, Oekraïne
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Hutchison Medipharma LimitedAstraZenecaVoltooidNiet-kleincellige longkankerChina
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Samsung Medical CenterVoltooidGeavanceerd Maag AdenocarcinoomKorea, republiek van