- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02650375
Study of Metatinib Tromethamine Tablet
20. januar 2017 oppdatert av: Jiangsu Simcere Pharmaceutical Co., Ltd.
A Phase Ib Clinical Study of the Tolerance, Safety and Preliminary Efficacy Observation of Single-/Multiple- Doses of Metatinib Tromethamine Tablets in Patients With Advanced or Metastatic Solid Tumor
This is an open-label, multicenter study designed to assess the safety, tolerability, preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous NSCLC.
Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred.
The study will determine whether MET gene mutation, amplification, as well as MET protein overexpression in tumor tissue correlate with treatment efficacy and clinical outcome.
The potential PD biomarker for Metatinib will also be explored.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
24
Fase
- Fase 1
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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Jilin
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Changchun, Jilin, Kina, 130021
- Rekruttering
- The First Bethune Hospital of Jilin University
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Ta kontakt med:
- Yanhua Ding, MD
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University
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Ta kontakt med:
- Feng Bi, MD
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310003
- Rekruttering
- The first affiliated hospital, Zhejiang university
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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
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients with advanced or metastatic gastric cancer or colorectal cancer who progress after second-line therapy or the above treatment protocol, or patients with advanced or metastatic hepatocellular carcinoma who progress after first-line chemotherapy, interventional therapy or targeted therapy shall be verified by histology or cytology; or patients with advanced or metastatic non-squamous non-small cell lung cancer who cannot be operated or fail to first-line therapy shall be verified by histology or cytology;
- MET gene amplification or protein overexpression(IHC ≥2+),or exon-14 skipping;
- At least one measurable lesion (RECIST 1.1 );
- At least 4 weeks from the last chemotherapy, radiotherapy or anti-tumor biological products treatment; at least 8 weeks from the last anti-tumor antibody products treatment; at least 6 weeks from the last dose of nitrosourea, mitomycin C or doxorubicin;
- At least 4 weeks from major surgery or trauma, and the wound should fully heal; at least 1 week from minor surgery or trauma (i.e. tissue biopsy or fine needle aspiration);
- Toxicity from previous treatment has to restore to ≤ grade 1, baseline or irreversible (NCI CTC4.0);
- ECOG performance status 0-1;
- Life expectancy ≥3 months;
- Adequate hematologic function: ANC≥1.5×10^9 /L, HB≥90g/L(blood transfusion allowed), PLT≥100×10^9/L;
- Adequate hepatic function: ALT≤3×ULN, AST≤3×ULN, TBIL≤2×ULN(patients with liver metastases or liver cancer ALT≤5×ULN, AST≤5×ULN, TBIL≤2×ULN), Child-Pugh score≤7;
- Adequate renal function: uric acid<500μmol/L, creatinine<1.7mg/dL, proteinuria≤2+or≤2g/24h , GFR≥60 ml/min/1.73m^2;
- PT-INR/APTT≤1.5×ULN, Serum sodium, potassium, calcium, magnesium levels ≤1×ULN(NCI-CTC 4.0);
- Patients signed written informed consent;
- Willingness and capability to comply with protocol requirement and well communicate with investigators.
Exclusion Criteria:
- Severe, uncontrolled medical disorders or active infection, including but not limited to HIV antibody positive, active tuberculosis, HBV DNA copies>10^3/ml;
- Subjects have known or suspected brain metastases;
- Patients must receive other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except for palliative local radiation) or traditional Chinese medicine for treatment of cancer during the study;
- Previously received other VEGF/VEGFR small-molecule inhibitors or antibodies therapy, including but not limited to Bevacizumab, Ramucirumab, Aflibercept;
- Previously received other HGF/c-Met small-molecule inhibitors or antibodies therapy, including but not limited to Crizotinib, Cabozantinib, Volitinib, Capmatinib (INC280), BPI-9016M;
- Imaging showed involvement of major blood vessels or nerves by tumor;
- Uncontrolled hypertension (systolic blood pressure>150mmHg and/or diastolic blood pressure>100mmHg after treatment);
- LVEF<50%;
- Apparent heart disease, including congestive heart failure(NYHA III-IV), history of myocardial infarction, or uncontrolled angina within 6 months prior to enrollment;
- Arrhythmias need to be treated, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or ventricular fibrillation; ECG abnormalities confirmed, including QT interval prolongation (males>450msec, females>470 msec);
- History of hemorrhagic or thrombotic events within 6 months before enrollment, i.e. cerebrovascular accidents(including TIA), pulmonary embolism, spontaneous hemorrhage of tumor;
- Patients need surgery within 28 days, or is expected to require surgery within 28 days after the last dose;
- Uncontrolled cavity effusion, such as large amount of pleural effusion and ascites;
- Gastrointestinal illnesses(i.e., uncontrolled diarrhea or malabsorption) at screening or within 3 months that may affect drug absorption;
- History or suspicious signs of gastrointestinal perforation;
- Concomitant medications that may affect the drug metabolism (i.e. strong CYP3A4 inhibitors or inducer );
- Pregnant or lactating women;
- Subjects of childbearing refused to use medically acceptable methods of contraception until 3 months after the last dose;
- Participate in other clinical trials within 4 weeks prior to enrollment;
- The investigators consider the patients are not suitable for this trial
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 |
---|---|
Eksperimentell: Metatinib Tromethamine
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Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
incidence of adverse events
Tidsramme: until 30 days after the last dose
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until 30 days after the last dose
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Objective response rate
Tidsramme: every 6 weeks, up to 2 years
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every 6 weeks, up to 2 years
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Disease control rate
Tidsramme: every 6 weeks, up to 2 years
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every 6 weeks, up to 2 years
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Progression free survival
Tidsramme: every 6 weeks, up to 2 years
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every 6 weeks, up to 2 years
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Overall survival
Tidsramme: every 6 weeks, up to 2 years
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every 6 weeks, up to 2 years
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Cmax for Metatinib
Tidsramme: day 1,day 2,day 8,day15,day22
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day 1,day 2,day 8,day15,day22
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Cmin for Metatinib
Tidsramme: day 1,day 2,day 8,day15,day22
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day 1,day 2,day 8,day15,day22
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Tmax for Metatinib
Tidsramme: day 1,day 2,day 8,day15,day22
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day 1,day 2,day 8,day15,day22
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AUC for Metatinib
Tidsramme: day 1,day 2,day 8,day15,day22
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day 1,day 2,day 8,day15,day22
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T1/2 for Metatinib
Tidsramme: day 1,day 2,day 8,day15,day22
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day 1,day 2,day 8,day15,day22
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CL for Metatinib
Tidsramme: day 1,day 2,day 8,day15,day22
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day 1,day 2,day 8,day15,day22
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Feng Bi, MD, West China Hospital
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
1. oktober 2015
Primær fullføring (Forventet)
1. oktober 2017
Studiet fullført (Forventet)
1. februar 2018
Datoer for studieregistrering
Først innsendt
10. november 2015
Først innsendt som oppfylte QC-kriteriene
7. januar 2016
Først lagt ut (Anslag)
8. januar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. januar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SIM-128-I-02
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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