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

11. mars 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

142

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: imexon + gemcitabine
Legemiddel: imexon in combination with gemcitabine
875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV
Andre navn:
  • Amplimexon, Gemzar
Aktiv komparator: Placebo + gemcitabine
Placebo in combination with gemcitabine
Legemiddel: imexon placebo + gemcitabine
imexon placebo IV + 1000 mg/m^2 gemcitabine IV
Andre navn:
  • Gemzar

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AmpliMed Corporation

Etterforskere

  • Studieleder: Evan Hersh, MD, AmpliMed Corporation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

1. april 2008

Primær fullføring (Faktiske)

1. mai 2010

Studiet fullført (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først innsendt

10. mars 2008

Først innsendt som oppfylte QC-kriteriene

10. mars 2008

Først lagt ut (Anslag)

17. mars 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AMP-019

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