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Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is Available

27. juni 2011 oppdatert av: Eli Lilly and Company

Phase I Study of Anti-Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Monoclonal Antibody IMC-3G3 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom no Standard Therapy is Available

The purpose of this study is to determine if IMC-3G3 is safe for patients, and also to determine the best dose of IMC-3G3 to give to patients.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-PDGFRα monoclonal antibody IMC-3G3 in patients with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

    • Indiana
      • Indianapolis, Indiana, Forente stater, 46282
        • ImClone Investigational Site
    • Texas
      • Houston, Texas, Forente stater, 77030
        • ImClone Investigational Site

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. Histopathological-documented, measurable, or non measurable, advanced primary tumor or recurrent solid tumor or lymphoma unresponsive to standard therapy or for which there is no standard therapy available.
  2. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry.
  3. Able to provide written informed consent.
  4. Age 18 years or older.
  5. Life expectancy of > 3 months.
  6. Adequate hematologic function, as defined by: an absolute neutrophil count ≥ 1500/mm3; a platelet count ≥ 100,000/mm3
  7. Adequate hepatic function, as defined by: a total bilirubin level ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x the ULN or ≤ 5 x the ULN if known liver metastases
  8. Adequate renal function, as defined by serum creatinine level ≤ 1.5 x the ULN.
  9. Uses effective contraception (per the institutional standard), if procreative potential exists.
  10. Adequate recovery from recent surgery, chemotherapy, and radiation therapy.
  11. Accessible for treatment and follow-up, must be treated at the participating center.

Exclusion Criteria:

  1. Received chemotherapy or therapeutic radiotherapy 28 days prior to the first dose of study medication or has ongoing side effects ≥ grade 2 due to agents administered more than 28 days earlier.
  2. Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring parenteral antibiotics; symptomatic congestive heart failure; unstable angina pectoris, angioplasty, stenting, or myocardial infarction 6 months prior to the first dose of study medication; uncontrolled hypertension; clinically significant cardiac arrhythmia including but not limited to: multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia; uncontrolled diabetes; psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
  3. Progressive or symptomatic brain metastases
  4. Has a serious or nonhealing active wound, ulcer, or bone fracture.
  5. Known human immunodeficiency virus positivity.
  6. Major surgical procedure, an open biopsy, or a significant traumatic injury 28 days prior to treatment.
  7. Is currently or has recently used (28 days prior to) a thrombolytic agent.
  8. Currently using full-dose warfarin (an exception is low-dose warfarin to maintain patency of pre-existing, permanent, indwelling intravenous [I.V.] catheters; for patients receiving warfarin, the international normalized ratio [INR] should be < 1.5). A patient requiring heparin is excluded.
  9. Undergoes chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function (cyclooxygenase-2 [COX-2] inhibitors are permitted).
  10. Has a history or clinical evidence of a deep venous or arterial thrombosis (including pulmonary embolism) 6 months prior to the first dose of study medication.
  11. Has proteinuria ≥ 2+ by routine urinalysis
  12. Pregnancy (confirmed by serum beta human chorionic gonadotropin) or lactating
  13. Received prior treatment with agents targeting the PDGFR ligand or receptor 6 weeks prior to the first dose of study medication.
  14. Received prior treatment with monoclonal antibodies 6 weeks prior to the first dose of study medication.
  15. Has a history of allergic reactions to monoclonal antibodies or other therapeutic proteins.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: IMC-3G3
All patients will receive intravenous infusions of IMC-3G3, with the dose depending on which cohort they are enrolled into.
Intravenously, once every week for Cohorts 1 through 3 and once every other week for Cohorts 4 and 5. Starting dose will be 4mg/kg in Cohort 1, with dose doubling between cohorts. Dose escalation of 100% (2 x previous dose) Dose escalation increment reduced to 33% (1.33 x previous dose). Cohorts 4 and 5 will receive 15mg/kg and 20mg/kg, intravenously, once every other week.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Summary of Participants Reporting Adverse Events
Tidsramme: Approximately 36 months
Approximately 36 months
Maximum Tolerated Dose (MTD)
Tidsramme: Approximately 36 months
After all patients complete a cohort, toxicity data is reviewed before the next cohort of patients is treated at the next higher dose level
Approximately 36 months

Sekundære resultatmål

Resultatmål
Tidsramme
Farmakokinetikk
Tidsramme: 6 uker
6 uker
Anti-IMC-3G3 Antibody Assessment
Tidsramme: Approximately 36 months
Approximately 36 months
Antitumor Activity of IMC-3G3 as Monotherapy
Tidsramme: 6 weeks
6 weeks
Pharmacodynamics
Tidsramme: 6 weeks
6 weeks

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studieleder: E-mail: ClinicalTrials@ ImClone.com, Eli Lilly and Company

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. desember 2006

Primær fullføring (Faktiske)

1. mars 2009

Studiet fullført (Faktiske)

1. januar 2010

Datoer for studieregistrering

Først innsendt

6. oktober 2008

Først innsendt som oppfylte QC-kriteriene

7. oktober 2008

Først lagt ut (Anslag)

8. oktober 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. juni 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juni 2011

Sist bekreftet

1. juni 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 13937
  • CP15-0601 (Annen identifikator: ImClone, LLC)
  • I5B-IE-JGDC (Annen identifikator: Eli Lilly and Company)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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