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A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

11. marts 2019 opdateret af: AmpliMed Corporation

A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)

The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

142

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Birmingham Hematology and Oncology- US Oncology
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85715
        • Arizona Clinical Research Center
      • Tucson, Arizona, Forenede Stater, 85704
        • AZ Onc Associates D.B.A. Hematology Oncology- US Oncology
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Center- US Oncology
    • Florida
      • Ocala, Florida, Forenede Stater, 34471
        • Ocala Oncology Center- US Oncology
      • Orlando, Florida, Forenede Stater, 34761
        • Cancer Centers of Florida- US Oncology
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Peachtree Hematology and Oncology Consultants
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Hematology Oncology Associates of Illinois- US Oncology
      • Niles, Illinois, Forenede Stater, 60714
        • Cancer Care & Hematolog Specialists of Chicagoland- US Oncology
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46227
        • Central Indiana Cancer Centers- US Oncology
      • South Bend, Indiana, Forenede Stater, 46601
        • Northern Indiana Cancer Research Consortium
      • Terre Haute, Indiana, Forenede Stater, 47802
        • Hope Center- US Oncology
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0093
        • University of Kentucky, Hematology/Oncology/BMT Clinical Research
    • Massachusetts
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Clinic
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64131
        • Kansas City Cancer Center, LLC- US Oncology
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Comprehensive Cancer Centers of Nevada- US Oncology
    • New Jersey
      • Flemington, New Jersey, Forenede Stater, 08822
        • Hunterdon Regional Cancer Center
      • Mount Holly, New Jersey, Forenede Stater, 08060
        • Hematology Oncology Associates
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • University of New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • Hematology Oncology Associates
      • Las Cruces, New Mexico, Forenede Stater, 88011
        • University of New Mexico Cancer Center South
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • New Mexico Cancer Care Associates- US Oncology
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Cancer Center of North Carolina- US Oncology
    • Pennsylvania
      • Kingston, Pennsylvania, Forenede Stater, 18704
        • Medical Onc Assoc of Wyoming Valley, PC- US Oncology
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • University of Pittsburgh Cancer Institute
      • Pottstown, Pennsylvania, Forenede Stater, 19464
        • Pottstown Memorial Medical Center
      • Upland, Pennsylvania, Forenede Stater, 19013
        • Associates in Hematology-Oncology P.C. US Oncology
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Reading Hospital Regional Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Sanford Clinic
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Texas Oncology - Amarillo- US Oncology
      • Beaumont, Texas, Forenede Stater, 77702
        • Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology
      • Bedford, Texas, Forenede Stater, 76022
        • Texas Oncology P.A.- Bedford- US Oncology
      • Dallas, Texas, Forenede Stater, 75230
        • Texas Cancer Center at Medical City- US Oncology
      • Dallas, Texas, Forenede Stater, 75231
        • Texas Oncology P.A. - Dallas- US Oncology
      • Dallas, Texas, Forenede Stater, 75237
        • Methodist Charlton Cancer Center - Texas Oncology- US Oncology
      • Odessa, Texas, Forenede Stater, 79761
        • Texas Oncology - Odessa- US Oncology
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Hospital and Clinics
      • Waco, Texas, Forenede Stater, 76712
        • Texas Oncology Cancer Care and Research Center- US Oncology
      • Wichita Falls, Texas, Forenede Stater, 76310
        • Texoma Cancer Center- US Oncology
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Virginia Oncology Associates- US Oncology
      • Salem, Virginia, Forenede Stater, 24153
        • Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Swedish Cancer Institute
      • Spokane, Washington, Forenede Stater, 99202
        • Cancer Care Northwest- US Oncology
      • Vancouver, Washington, Forenede Stater, 98684
        • Northwest Cancer Specialists- US Oncology

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:

  1. Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
  2. At least one unidimensional measurable metastatic lesion by contrast enhanced CT scan (or MRI in patients ineligible for contrast enhanced CT) that are outside any prior radiation port.
  3. Age at least 18 years.
  4. ECOG performance status 0 or 1.
  5. No prior chemotherapy or radiation therapy.
  6. Projected life expectancy at least 2 months.
  7. If female, neither pregnant nor lactating.
  8. If of child bearing potential must agree to, and be able to use adequate contraception.
  9. Concomitant disease: No respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life threatening ventricular arrhythmias. No uncompensated CHF or NY Heart Association class 3 or 4 cardiac disease.
  10. No other concurrent active malignancy.
  11. No infection requiring parenteral antibiotic therapy at the start of protocol treatment.

  12. Laboratory values within the following criteria:

    Hgb greater than or equal to 9 gm/dL WBC greater than or equal 3,500/mm^3 ANC greater than or equal 1,500/mm^3 Platelet count greater than or equal 100,000/mm^3 Creatinine greater than or equal 2.0 Bilirubin less than or equal to 2.0 Hepatic enzymes (AST, ALT) less than or equal 3 times upper limit of normal (ULN)

  13. G6PD level greater than or equal lower limit of normal (LLN).
  14. Able to render informed consent and follow protocol requirements.

Exclusion Criteria:

  1. Patients with locally advanced, non-metastatic pancreas cancer (Stage III or below).
  2. Age less than 18 years.
  3. ECOG performance status 2 or greater.
  4. Prior anticancer drug therapy for metastatic disease.
  5. Ascites.
  6. Prior abdominal or thoracic surgery < 4 weeks before the start of therapy.
  7. Current or prior brain metastases. Brain MRI or CT required pre-registration only if the patient has CNS symptoms indicating a need for evaluation.
  8. Life expectancy projected less than 2 months.
  9. Pregnancy or lactation.
  10. Unable or unwilling to utilize medically acceptable contraception if of childbearing potential.
  11. Laboratory parameters outside of specified ranges, (see above).
  12. Infection requiring parenteral antibiotics.
  13. NY Heart Association stage 3 or 4 heart disease.
  14. Unable to render informed consent.
  15. Failure to meet any of the eligibility criteria as outlined above.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: imexon + gemcitabine
Medicin: imexon in combination with gemcitabine
875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV
Andre navne:
  • Amplimexon, Gemzar
Aktiv komparator: Placebo + gemcitabine
Placebo in combination with gemcitabine
Medicin: imexon placebo + gemcitabine
imexon placebo IV + 1000 mg/m^2 gemcitabine IV
Andre navne:
  • Gemzar

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival for the Intent to Treat Population
Tidsramme: up to 2 years
To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
up to 2 years
To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events
Tidsramme: Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months
Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events
Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rates of the Two Treatment Arms
Tidsramme: one year
Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.
one year
Progression Free Survival
Tidsramme: one year
To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
one year

Samarbejdspartnere og efterforskere

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

Sponsor

AmpliMed Corporation

Efterforskere

  • Studieleder: Evan Hersh, MD, AmpliMed Corporation

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)

1. april 2008

Primær færdiggørelse (Faktiske)

1. maj 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

10. marts 2008

Først indsendt, der opfyldte QC-kriterier

10. marts 2008

Først opslået (Skøn)

17. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AMP-019

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 .

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