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A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

27. juni 2018 opdateret af: Puma Biotechnology, Inc.

A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer

The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

110

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Brussels, Belgien, 1000
        • Institut Jules Bordet Unite du Chimiotherapie
      • Gent, Belgien, 9000
        • Universitair Ziekenhuis Gent
      • Kortrijk, Belgien, 8500
        • AZ Groeninge Campus Maria's Voorzienigheid (MV)
      • Wilrijk, Belgien, 2610
        • Oncologisch Centrum GZA - Location St Augustinus
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital University Health Network
  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92093
        • Moores UC San Diego Cancer Center
      • La Jolla, California, Forenede Stater, 92037
        • Scripps, Clinic General
      • San Diego, California, Forenede Stater, 92123
        • Sharp Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston University Medical Center
    • Michigan
      • Lansing, Michigan, Forenede Stater, 48912
        • Mid-Michigan Physicians-HOS Division
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Oncology Care Associates
    • New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • CTRC at The University of Texas Health Science Center
  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Medicine, Queen Mary Hospital
      • Hong Kong, Hong Kong
        • UNIMED Medical Institute
      • Hong Kong, Hong Kong
        • Department of Surgery Queen Mary Hospital
  • Indien
    • Maharashtra
      • Pune, Maharashtra, Indien, 411001
        • Jehangir Clinical Development Centre, Jehangir Hospital Premises
      • Pune, Maharashtra, Indien, 411004
        • M.M.F. Joshi Hospital & Ratna Memorial Hospital
    • Parel
      • Mumbai, Parel, Indien, 400012
        • Tata Memorial Hospital
    • Rajasthan
      • Jaipur, Rajasthan, Indien, 302004
        • Birla Cancer Centre, S.M.S. Medical College & Hospital
  • Kina
      • Beijing, Kina, 100021
        • Cancer hospital, Chinese Academy of Medical Sciences
      • Beijing, Kina, 100032
        • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
    • Beijing
      • Beijing, Beijing, Kina, 100071
        • The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
      • Beijing, Beijing, Kina, 100853
        • Chinese People's Liberation Army General Hospital
    • Tianjin
      • TianJin, Tianjin, Kina, 300060
        • Tianjin cancer hospital
      • Tianjin, Tianjin, Kina, 300121
        • Tianjin Union Medicine Center Department of Oncology
  • Korea, Republikken
      • Seoul, Korea, Republikken, 120-752
        • Yonsei University Health System - Severance Hospital
      • Seoul, Korea, Republikken, 138-736
        • Asan Medical Center, Division of Oncology, Department of Internal Medicine
  • Polen
      • Krakow, Polen, 31-826
        • Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera, Oddzial Onkologii
      • Lublin, Polen, 20-090
        • Oddzial Chemioterapii Centrum Onkologii Ziemii Lubelskiej
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • City Multifield Clinical Hospital #4 Department of chemotherapy, Dnipropetrovs'k State Medical Academy, Chair of Oncology and Medical Radiology
      • Lviv, Ukraine, 79031
        • State Oncological Regional Treatment and Diagnostic Center Department of chemotherapy

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:

Inclusion criteria for both parts of clinical trial:

  • Good performance status
  • Normal ejection fraction
  • Adequate cardiac, kidney, and liver function
  • Adequate blood counts
  • At least one measurable target lesion
  • Negative pregnancy test for female subjects

Inclusion Criteria for Part 1 Only:

- Pathologically confirmed solid tumor not curable with available standard therapy

Inclusion Criteria for Part 2 Only:

  • Pathologically confirmed breast cancer
  • HER2 positive tumor
  • Prior treatment with Herceptin

Exclusion Criteria:

Exclusion criteria for both parts of clinical trial:

  • Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1
  • Subjects with bone or skin as the only site of disease
  • Active central nervous system metastases
  • Significant cardiac disease or dysfunction
  • Significant gastrointestinal disorder
  • Inability or unwillingness to swallow HKI-272 capsules
  • Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.
  • Treatment with a taxane within 3 months of treatment day 1
  • Grade 2 or greater motor or sensory neuropathy
  • Pregnant or breast feeding women
  • Known hypersensitivity to paclitaxel or Cremophor EL
  • Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
  • Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin

Exclusion Criteria for Part 2 Only:

- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease

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: HKI-272 dose level 1
Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 160 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
Medicin: Paclitaxel
Medicin: HKI-272
Andre navne:
  • Neratinib
Eksperimentel: HKI-272 dose level 2
Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
Medicin: Paclitaxel
Medicin: HKI-272
Andre navne:
  • Neratinib
Eksperimentel: HKI-272 expanded MTD cohort, arm A
Part 2: Subjects with metastatic breast cancer who have not received more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
Medicin: Paclitaxel
Medicin: HKI-272
Andre navne:
  • Neratinib
Eksperimentel: HKI-272 expanded MTD cohort, arm B
Part 2: Subjects with metastatic breast cancer who have not received more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
Medicin: Paclitaxel
Medicin: HKI-272
Andre navne:
  • Neratinib

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel
Tidsramme: From first dose date through day 28
Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
From first dose date through day 28
Maximum Tolerated Dose
Tidsramme: From first dose date through day 28.
Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with paclitaxel 80 mg/m², intravenous at days 1, 8, and 15, associated with the dose limiting toxicity data.
From first dose date through day 28.
Objective Response Rate
Tidsramme: From first dose date to progression or last tumor assessment, up to 140 weeks
Subjects with partial response (PR) or complete response (CR) with ERBB2 positive breast cancer treated at the maximum tolerated dose (MTD) of neratinib in combination with paclitaxel, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and no progressive disease (PD) for non-target lesions, and no new lesions.
From first dose date to progression or last tumor assessment, up to 140 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Plasma Concentration of Neratinib
Tidsramme: Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Maximum plasma concentration of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.
Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Area Under the Concentration-time Curve 0-24
Tidsramme: Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Area under the concentration-time curve of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.
Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.

Samarbejdspartnere og efterforskere

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

Sponsor

Puma Biotechnology, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

11. september 2007

Primær færdiggørelse (Faktiske)

1. maj 2011

Studieafslutning (Faktiske)

7. februar 2018

Datoer for studieregistrering

Først indsendt

8. marts 2007

Først indsendt, der opfyldte QC-kriterier

8. marts 2007

Først opslået (Skøn)

9. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3144A1-203 / B1891014

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Brystneoplasmer

Kliniske forsøg med Paclitaxel

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in France

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner