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Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments

26. august 2014 opdateret af: Nanjing Luye Sike Pharmaceutical Co., Ltd.
The purpose of this study is to determine the maximum tolerated dose (MTD)of paclitaxel liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome injection and paclitaxel injection and to value the effectiveness for cancer treatment.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

36

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100032
        • Rekruttering
        • Peking Union Medical College Hospital
        • Kontakt:
          • Ji Jiang
      • Beijing, Beijing, Kina, 100142
        • Rekruttering
        • Beijing Cancer Hospital
        • Kontakt:
      • Beijing, Beijing, Kina, 100142
        • Ikke rekrutterer endnu
        • No.52 Fucheng Road, Haidian District,Beijing,
        • Ledende efterforsker:
          • Lin Shen
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patient willing to sign an Investigational Review Board(IRB) approved written informed consent document
  • patient age: 18 years -75years
  • patient must have histologically confirmed solid tumor
  • patient must have uncurable and unresectable solid tumor of advanced stages
  • patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • patient must have a life expectancy at least 12 weeks
  • patient must have at least one lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
  • patient must have progress or recurrence after at least one chemotherapy regimen for advanced stage
  • patient must have adequate marrow,hepatic and renal function: defined as ANC≥2.0 × 109/L，PLT ≥10 ×109/dL, Hb ≥ 9g/dL;GOT/GPT≤2.5×ULN；Toltle bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN or Creatinine clearance≥40ml/min(according to Cockcroft-Gault；
  • patient must have the left ventricular ejection fraction (LVEF)≥50% confirmed by ultrasonic heart scanning
  • women must have the negative pregnancy test; women and men must agree to use adequate contraception

Exclusion Criteria:

  • patient must non have received any other antitumor therapy, including chemotherapy, radiotherapy, hormonal therapy, biological therapy, immunotherapy and any other investigational agent within 4 weeks prior to starting study
  • patient must non have any pre-existing toxity from prior antitumor therapy (any≥ grade 2, any≥1 peripheral neuropathy, excluding alopecia)
  • patient must non have uncontrolled cerebral metastases
  • patient must non have any uncontrolled heart illness including, but not limited to, ongoing symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, arterial hypertension (≥180/110), heart failure and myocardial infarction within 6 months prior to starting study
  • Patient must not have a history of a malignancy tumor except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix for at least 5 years
  • patient must non have any serious illness including, but not limited to hepatic, renal, respiratory and uncontrolled diabetes mellitus
  • patient must non have psychiatric illness/social situations that would limit compliance with study requirements.
  • patient must non have active or uncontrolled infection including, but not limited to tuberculosis,HIV,HBV, HCV
  • Patient must non be receiving any other antitumor agent
  • patient must non be pregnant and/or breastfeeding
  • patient must non be receiving protease inhibitors,inhibitors of CYP3A4,antifungal agents and inducing agent of CYP3A4

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dose level A
Paclitaxel liposome injection 135mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Medicin: Paclitaxel liposome injection
Andre navne:
  • LIPUSU®
Eksperimentel: Dose level B
Paclitaxel liposome injection 175mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Medicin: Paclitaxel liposome injection
Andre navne:
  • LIPUSU®
Eksperimentel: Dose level C
Paclitaxel liposome injection 210mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Medicin: Paclitaxel liposome injection
Andre navne:
  • LIPUSU®
Eksperimentel: Dose level D
Paclitaxel liposome injection 250mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Medicin: Paclitaxel liposome injection
Andre navne:
  • LIPUSU®
Eksperimentel: Dose level E
Paclitaxel liposome injection 300mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days
Medicin: Paclitaxel liposome injection
Andre navne:
  • LIPUSU®
Aktiv komparator: Comparator
Paclitaxel injection 175mg/m2 on day 1, each 21 days
Medicin: Paclitaxel injection
Andre navne:
  • Taxol®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum tolerated dose(MTD)of paclitaxel liposome injection
Tidsramme: completion of cycle 1(28 days)
Graded and described using National Cancer Institute(NCI)Common Terminology Criteria for adverse events (CTCAE 4.0)
completion of cycle 1(28 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
dose-limiting toxicities(DLTs) of paclitaxel liposome injection
Tidsramme: completion of cycle 1 (28 days)
Graded and described using National Cancer Institute(NCI)Common Terminology Criteria for adverse events (CTCAE 4.0)
completion of cycle 1 (28 days)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetic characters of paclitaxel liposome injection compared with paclitaxel injection
Tidsramme: 0,during infusion 1.5h, 3h, after infusion 15min, 30min, 1h,2h,4h,8h,12h,24h,36h,48h,72 h
Peak Plasma Concentration(Cmax), peak time (Tmax), Half life(T1/2), Area under the plasma concentration versus time curve(AUC0-t), Clearance (CL/F), Apparent volume of distribution(Vd/F), Mean Residence Time (MRT),
0,during infusion 1.5h, 3h, after infusion 15min, 30min, 1h,2h,4h,8h,12h,24h,36h,48h,72 h

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanjing Luye Sike Pharmaceutical Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2014

Primær færdiggørelse (Forventet)

1. juli 2015

Datoer for studieregistrering

Først indsendt

31. oktober 2013

Først indsendt, der opfyldte QC-kriterier

20. november 2013

Først opslået (Skøn)

25. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NJLYSK-LPS-2013-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Faste tumorer

Kliniske forsøg med Paclitaxel liposome injection

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