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ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma

30. juni 2015 oppdatert av: Active Biotech AB

A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.

The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

526

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"
      • Plovdiv, Bulgaria, 4004
        • 1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital
      • Sofia, Bulgaria, 1431
        • Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology
      • Sofia, Bulgaria, 1527
        • Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"
      • Varna, Bulgaria, 9002
        • Urology Clinic, General Hospital for Active Treatment "St. Anna"
      • Veliko Tarnovo, Bulgaria, 5000
        • Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital
  • Den russiske føderasjonen
      • Arkhangelsk, Den russiske føderasjonen
        • Arkhangelsk Regional Oncology Center
      • Chelyabinsk, Den russiske føderasjonen, 454087
        • Chelyabinsk Regional Oncology Center
      • Kazan, Den russiske føderasjonen, 420029
        • Republican Clinical Oncology Center
      • Kazan, Den russiske føderasjonen, 420111
        • Kazan City Oncology Center
      • Moscow, Den russiske føderasjonen, 115478
        • Russian Oncological Research Center n.a. N.N. Blokhin
      • Moscow, Den russiske føderasjonen, 105425
        • Research Institute of Urology
      • Moscow, Den russiske føderasjonen, 117997
        • Russian Research Center of Radiology
      • Obninsk, Den russiske føderasjonen, 249036
        • Medical Radiology Research Center
      • Orenburg, Den russiske føderasjonen, 460021
        • Orenburg Regional Clinical Oncology Center
      • St. Petersburg, Den russiske føderasjonen, 191104
        • Leningrad Regional Oncological Center
      • St. Petersburg, Den russiske føderasjonen, 193312
        • Municipal Aleksandrovskaya Hospital
      • St. Petersburg, Den russiske føderasjonen, 194354
        • Municipal Multi-Speciality Hospital #2
      • St. Petersburg, Den russiske føderasjonen, 196247
        • Municipal Hospital #26
      • St. Petersburg, Den russiske føderasjonen, 197022
        • Municipal Clinical Oncology Center
      • St. Petersburg, Den russiske føderasjonen, 197758
        • Central Research Institute of Roentgenology and Radiology
      • St. Petersburg, Den russiske føderasjonen, 197758
        • Research Institute of Oncology n.a. Professor N.N. Petrov
      • St. Petersburg, Den russiske føderasjonen, 198205
        • Municipal Hospital #15
      • Stavropol, Den russiske føderasjonen, 355047
        • Stavropol Territorial Clinical Oncology Center
      • Yaroslavl, Den russiske føderasjonen, 150054
        • Regional Clinical Oncology Hospital
  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute - Urology Department
      • Bucharest, Romania, 041345
        • Dinu Uromedica
      • Bucharest, Romania, 050659
        • "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
      • Cluj Napoca, Romania, 400015
        • "I. Chiricuta" Institute of Oncology
      • Cluj Napoca, Romania, 400016
        • E-URO Medical Center
      • Constanta, Romania, 900635
        • Provita Center SRL
      • Sibiu, Romania, 550245
        • Sibiu Clinical Country Hospital - Urology Clinic
      • Timisoara, Romania, 300239
        • Oncomed SRL
  • Storbritannia
      • Cambridge, Storbritannia, CB2 0QQ
        • Addenbrooke's Hospital, Cambridge Clinical Trials Centre
      • Derby, Storbritannia, DE1 2QY
        • Derby Hospital NHS Trust
      • Glasgow, Storbritannia, G12 0YN
        • The Beatson West of Scotland Cancer Centre
      • Leeds, Storbritannia, LS9 7TF
        • St. James's Institute of Oncology
      • London, Storbritannia, SW6 6JJ
        • The Royal Marsden NHS Trust
      • Manchester, Storbritannia, M20 4BX
        • The Christie Hospital NHS Trust
      • Swansea, Storbritannia, SA2 8QA
        • South Wales Cancer Institute, Singleton Hospital
  • Ukraina
      • Cherkassy, Ukraina, 18009
        • Cherkassy Regional Oncology Center
      • Chernigov, Ukraina, 14029
        • Chernigov Regional Oncology Center
      • Dnepropetrovsk, Ukraina, 49005
        • Urology Department, Dnepropetrovsk State Medical Academy
      • Dnepropetrovsk, Ukraina, 49102
        • City General Hospital #4
      • Donetsk, Ukraina, 83092
        • Donetsk Regional Antitumor Center
      • Ivano-Frankovsk, Ukraina, 76000
        • Ivano-Frankovsk Regional Oncology Center
      • Kharkiv, Ukraina, 61037
        • Kharkiv Regional Urology and Nephrology Center
      • Kiev, Ukraina, 04053
        • Institute of Urology under the Academy of Medical Sciences of Ukraine, Department of Plastic and Supportive Urology
      • Kiev, Ukraina, 04053
        • Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department
      • Lvov, Ukraina, 79031
        • State Regional Diagnostics and Treatment Oncology Center
      • Uzhorod, Ukraina, 88014
        • Regional Oncology Center

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:

  • Histologically or cytologically confirmed RCC (clear cell and papillary types)
  • Metastatic or inoperable locally advanced RCC
  • Eligible for therapy with IFN-alpha.
  • Measurable disease defined by at least 1 measurable lesion on CT scan (lesion diameter greater than or equal to 2.0 cm by a standard CT scanner or greater than or equal to 1.0 cm by a spiral CT scanner)
  • Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2)
  • Karnofsky performance status greater than or equal to 70
  • Age greater than or equal to 18
  • Life expectancy greater than 3 months

  • Baseline blood counts:

    • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
    • Platelets greater than or equal to 100 x 10^9/L
    • Haemoglobin greater than or equal to 100 g/L

  • Baseline blood chemistry levels:

    • Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
    • Bilirubin less than or equal to 2 x ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. AST and ALT allowed less than or equal to 5 x ULN for patients with liver metastases.
  • If fertile, patient will use effective method of contraception throughout the study
  • Willing and able to comply with the treatment and follow-up visits and examinations
  • Capable of understanding the parameters in the protocol and able to sign a written consent form

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Serious uncontrolled medical disorder or active infection ongoing or resolved within 2 weeks before first dose of study drug and that the investigator believes would impair the patient's ability to receive study drug
  • History of malignancy within 5 years or concurrent malignancy, except successfully treated non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ or lobular carcinoma in situ of breast may be included
  • History and/or signs of parenchymal brain metastases
  • Significant cardiac disease including: history (within 6 months) or current unstable angina pectoris, congestive heart failure (NYHA stage III-IV), myocardial infarction within 12 months, or uncontrolled arterial hypertension.
  • History of stroke within 5 years and/or transient ischemic attack within 6 months.
  • Acute illness or evidence of infection, including unexplained fever (>100.5ºF or 38.1ºC) within 2 weeks before start of treatment
  • Treatment with biological response modifiers within 3 weeks prior to the start of treatment and up to the End-of-Study visit
  • Treatment with beta-blockers, including topical therapy for glaucoma, within 5 days before start of treatment and during the 4-day ABR-217620/naptumomab estafenatox treatment
  • Treatment with systemic corticosteroids within 2 weeks before start of treatment or likely need for such treatment during the study
  • Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis
  • Known positive serology for HIV
  • Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of chronic virus hepatitis or known virus carrying; patients who recovered from Hepatitis A are allowed
  • Treatment with anticoagulants within 2 weeks before start of treatment, except when used to maintain the patency of a central or peripheral venous line
  • Radiotherapy less than 4 weeks before start of treatment
  • Major surgery or tumor embolization less than 4 weeks before start of treatment
  • Previous exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins
  • Currently on renal dialysis treatment
  • Known allergy or hypersensitivity to aminoglycosides and kanamycin
  • Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-alpha or IL-2 or any chemotherapy) except sunitinib or other oral antiangiogenic therapy
  • Participation in any study with investigational drugs for RCC within 6 weeks

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Legemiddel: ABR-217620/naptumomab estafenatox
10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
Andre navn:
  • naptumomab estafenatox
Legemiddel: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andre navn:
  • Referon-A
Eksperimentell: Safety group
6-12 patients
Legemiddel: ABR-217620/naptumomab estafenatox
10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
Andre navn:
  • naptumomab estafenatox
Legemiddel: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andre navn:
  • Referon-A
Annen: 2
Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
Legemiddel: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andre navn:
  • Referon-A

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Time to death
Tidsramme: every 12 weeks, including after a maximum of 18 months of study treatment
every 12 weeks, including after a maximum of 18 months of study treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Progression-free survival time
Tidsramme: every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
Objective tumor response rate
Tidsramme: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Best overall response
Tidsramme: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Duration of response
Tidsramme: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Changes in sum of target lesions
Tidsramme: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Immunological response in patients on combined treatment of ABR-217620/naptumomab estafenatox and IFN-alpha
Tidsramme: Weeks 1, 9, 17, 25, 73
Weeks 1, 9, 17, 25, 73
Vital signs
Tidsramme: every visit through Week 25, plus Week 73
every visit through Week 25, plus Week 73
Physical measurements
Tidsramme: Weeks 1, 9, 17, 25, 73
Weeks 1, 9, 17, 25, 73
Adverse events
Tidsramme: every visit through Week 73
every visit through Week 73
Laboratory safety assessments
Tidsramme: Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
Pharmacokinetic parameters of ABR-217620/naptumomab estafenatox
Tidsramme: Weeks 1, 9, and 17
Weeks 1, 9, and 17

Samarbeidspartnere og etterforskere

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

Sponsor

Active Biotech AB

Etterforskere

  • Studieleder: Thore Nederman, PhD, Active Biotech AB

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

1. januar 2007

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

9. januar 2007

Først innsendt som oppfylte QC-kriteriene

9. januar 2007

Først lagt ut (Anslag)

11. januar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

22. juli 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2015

Sist bekreftet

1. juni 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 06762004

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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