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Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

11. juli 2014 oppdatert av: Bayer

Radium-223 Chloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product.

Studieoversikt

Status

Ikke lenger tilgjengelig

Forhold

Intervensjon / Behandling

Studietype

Utvidet tilgang

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, 35233
    • Arizona
      • Phoenix, Arizona, Forente stater, 85040
      • Scottsdale, Arizona, Forente stater, 85260
    • California
      • Greenbrae, California, Forente stater, 94904
      • La Jolla, California, Forente stater, 92093
      • San Francisco, California, Forente stater, 94143
      • Stanford, California, Forente stater, 94305
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
    • Delaware
      • Newark, Delaware, Forente stater, 19718
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20007
      • Washington, District of Columbia, Forente stater, 20060
    • Florida
      • Fort Myers, Florida, Forente stater, 33901
      • Miami Beach, Florida, Forente stater, 33140
      • Tampa, Florida, Forente stater, 33612
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813-2413
    • Indiana
      • Goshen, Indiana, Forente stater, 46526
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
      • Shreveport, Louisiana, Forente stater, 71103
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
      • Baltimore, Maryland, Forente stater, 21229
      • Baltimore, Maryland, Forente stater, 21201-1595
      • Bethesda, Maryland, Forente stater, 20889
      • Rockville, Maryland, Forente stater, 20850
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
      • Boston, Massachusetts, Forente stater, 02114
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0028
      • Detroit, Michigan, Forente stater, 48201
      • Detroit, Michigan, Forente stater, 48202
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
    • Missouri
      • St. Louis, Missouri, Forente stater, 63110
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89169
    • New Jersey
      • New Brunswick, New Jersey, Forente stater, 08903-2681
      • Newark, New Jersey, Forente stater, 07103
    • New York
      • New Hyde Park, New York, Forente stater, 11040-1496
      • New York, New York, Forente stater, 10016
      • New York, New York, Forente stater, 10065
      • Syracuse, New York, Forente stater, 13210
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
      • Raleigh, North Carolina, Forente stater, 27607
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
      • Columbus, Ohio, Forente stater, 43212
    • Oregon
      • Springfield, Oregon, Forente stater, 97477
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
      • Philadelphia, Pennsylvania, Forente stater, 19111-2497
      • Philadelphia, Pennsylvania, Forente stater, 19401
      • Pittsburgh, Pennsylvania, Forente stater, 15213
    • South Carolina
      • Myrtle Beach, South Carolina, Forente stater, 29572
      • Myrtle Beach, South Carolina, Forente stater, 29577
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
    • Texas
      • Houston, Texas, Forente stater, 77030
      • Plano, Texas, Forente stater, 75093
      • San Antonio, Texas, Forente stater, 78229
      • Temple, Texas, Forente stater, 76508
    • Virginia
      • Hampton, Virginia, Forente stater, 23666
      • Norfolk, Virginia, Forente stater, 23507
    • Washington
      • Seattle, Washington, Forente stater, 98122
    • West Virginia
      • Wheeling, West Virginia, Forente stater, 26003
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226-3596

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

N/A

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically or cytologically confirmed prostate cancer
  • Patients diagnosed with symptomatic progressive bone predominant metastatic CRPC/HRPC with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)

  • Symptomatic is defined as either

    • Regular (not occasional) use of analgesic medication for cancer related bone pain (≥ level 1; World Health Organization [WHO] ladder for cancer pain), or
    • Treatment with external beam radiation therapy (EBRT) for bone pain (the EBRT should be within the last 12 weeks before treatment)

  • Progressive disease is defined either by:

    • The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), then PSA values from 3 assessments within the last 6 months must be provided; OR
    • In the absence of new bone lesions, 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but, the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met).
  • No intention to use cytotoxic chemotherapy within the next 6 months
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

  • Adequate hematological, liver, and renal function

    • Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
    • Platelet count ≥ 100 x10^9/L
    • Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
    • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Creatinine ≤ 1.5 x ULN
    • Albumin > 25 g/L *Any bone imaging techniques as per institutional standard of care

Exclusion Criteria:

  • Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
  • Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
  • Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events (AEs) due to cytotoxic chemotherapy administered more than 4 weeks previous prior to screening (however, ongoing neuropathy is permitted)
  • Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count, and platelets
  • Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
  • Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
  • Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
  • Presence of brain metastases
  • Lymphadenopathy exceeding 6 cm in short-axis diameter
  • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
  • Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.

  • Any other serious illness or medical condition, such as but not limited to:

    • Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
    • Cardiac Failure New York Heart Association (NYHA) Class III or IV
    • Crohn's disease or ulcerative colitis
    • Bone marrow dysplasia
  • Fecal incontinence

Studieplan

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

Hvordan er studiet utformet?

Samarbeidspartnere og etterforskere

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

Sponsor

Bayer

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.

Datoer for studieregistrering

Først innsendt

20. januar 2012

Først innsendt som oppfylte QC-kriteriene

20. januar 2012

Først lagt ut (Anslag)

25. januar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juli 2014

Sist bekreftet

1. juli 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 15995
  • 2011-004469-33 (EudraCT-nummer)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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