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Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment

3. december 2013 opdateret af: Sanofi

An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function

Primary Objective:

- To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel

Secondary Objective:

- To assess the safety of cabazitaxel in patients with various degrees of renal impairment

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first.

Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Bruxelles, Belgien, 1200
        • Investigational Site Number 056002
      • Gent, Belgien, 9000
        • Investigational Site Number 056001
  • Det Forenede Kongerige
      • Cambridge, Det Forenede Kongerige, CB2 2QQ
        • Investigational Site Number 826001
  • Holland
      • Rotterdam, Holland, 3075 EA
        • Investigational Site Number 528001
      • Utrecht, Holland, 3584 CX
        • Investigational Site Number 528002
  • Italien
      • Milano, Italien, 20133
        • Investigational Site Number 380001
  • Spanien
      • Barcelona, Spanien, 08035
        • Investigational Site Number 724001

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria :

  • Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator.
  • Eastern Cooperative Oncology Group performance status 0 - 2
  • Stable renal function

  • Patients must have adequate liver and marrow function as defined below:

    • Absolute neutrophil count ≥ 1.5x10^9/L
    • Platelets ≥ 100x10^9/L
    • Total bilirubin ≤ 1.0 x the institutions upper limit of normal
    • AST (SGOT)/ALT (SGPT) ≤ 2.5 x the institutions upper limit of normal
    • Alkaline phosphatase ≤ 2.5 x the institutions upper limit of normal
  • Patient may have a Grade 1 or less neurotoxicity at study entry.
  • Life expectancy > 3 months
  • Age ≥ 18 years old
  • If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
  • Having given written informed consent prior to any procedure related to the study

Exclusion criteria:

  • Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to ≥ 30% of bone marrow are not allowed.
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, class III or IV congestive heart failure, stroke or transient ischemic attack.
  • Any of the following within 3 months prior to study start: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
  • Active hepatitis
  • Acute renal failure (new or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.
  • Patients requiring dialysis during the study.
  • History of hypersensitivity to docetaxel or polysorbate 80.
  • Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
  • Known brain metastases.
  • If female, pregnancy or breast-feeding.
  • Any treatment known to induce CYP isoenzymes (e.g., phenobarbital, phenytoin, carbamazepine, rifampicin, St John's Wort) or to strongly inhibit CYP3A4 activities (e.g., ketoconazole, itraconazole, macrolides, antiprotease agents, etc) is not allowed within 2 weeks before or during the test period of the pharmacokinetic sampling

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Cohort A
Normal renal function - Cabazitaxel administered once every 3 weeks
Medicin: Cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous
Eksperimentel: Cohort B
Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks
Medicin: Cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous
Eksperimentel: Cohort C
Severe renal dysfunction - Cabazitaxel administered once every 3 weeks
Medicin: Cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Pharmacokinetic profile of cabazitaxel in study population
Tidsramme: Up to day 10
Up to day 10

Sekundære resultatmål

Resultatmål
Tidsramme
Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters
Tidsramme: up to 30 days after the last dosing
up to 30 days after the last dosing

Samarbejdspartnere og efterforskere

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

Sponsor

Sanofi

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. april 2012

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

2. februar 2012

Først indsendt, der opfyldte QC-kriterier

6. februar 2012

Først opslået (Skøn)

7. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • POP12251
  • 2011-001517-14 (EudraCT nummer)
  • U1111-1121-4512 (Anden identifikator: UTN)

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 Neoplasma ondartet

Kliniske forsøg med Cabazitaxel XRP6258

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Indonesia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner