- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00082134
Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
4. mars 2015 oppdatert av: Genzyme, a Sanofi Company
A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel.
Approximately 40 patients will be enrolled in this study that is expected to last 24 months.
All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days.
The primary objective of this study is to determine the PSA response rate.
The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.
Studieoversikt
Studietype
Intervensjonell
Registrering
40
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Tucson, Arizona, Forente stater
- Arizona Clinical Research Center
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Kansas
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Lenexa, Kansas, Forente stater
- Kansas City Cancer Centers
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Overland Park, Kansas, Forente stater
- Kansas City Cancer Centers
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Missouri
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Kansas City, Missouri, Forente stater
- Kansas City Cancer Centers- Central
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North Carolina
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Cary, North Carolina, Forente stater
- Cancer Center of North Carolina- Cary
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Oregon
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Portland, Oregon, Forente stater
- Oregon Health and Science University
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Texas
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Dallas, Texas, Forente stater
- Texas Cancer Center at Medical City
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Dallas, Texas, Forente stater
- Sammons Cancer Center
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Lubbock, Texas, Forente stater
- Joe Arrington Cancer Center
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Plano, Texas, Forente stater
- North Texas Regional Cancer Center
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Washington
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Seattle, Washington, Forente stater
- Swedish Cancer Institute
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Spokane, Washington, Forente stater, 99218
- Cancer Care Northwest
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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
19 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Patient has hormone-refractory prostate cancer (HRPC) as evidenced by PSA progression or progression of measurable disease.
- Patient has greater than 25% increase in 2 consecutive tests in which the first increase in PSA should occur a minimum of 1 week apart.
- Patients on androgen deprivation treatment and will continue on androgen deprivation treatment during study participation except for patients who are post orchiectomy.
- Patient has evidence of metastatic disease by positive bone scan or evidence of progressive metastatic disease by CT scan.
- Patient has been treated with at least 1 prior hormone therapy or is post orchiectomy.
- Patient has been previously treated at a minimum for an 8-week treatment period on a docetaxel-based regimen for metastatic HRPC.
- Patient has PSA at least 5 ng/mL or greater.
- Patient has testosterone less than 50 ng/dL.
- Patient ECOG performance status of 0 or 1.
- Patient has life expectancy of greater than 8 weeks.
- Patient meets lab values: A. Absolute neutrophil count at least 1,500/mm^3 or greater; B.Platelet count at least 100,000/mm^3 or greater; C. Serum creatinine at least 1.5 mg/dL or less or creatinine clearance at least 60 mL/min or greater; D. Bilirubin less than 2.0 mg/dL. E. AST and ALT less or equal to 2.5 times upper limit of normal
- Any chemotherapy, major surgery, or irradiation must be completed at least 4 weeks prior to study drug.
- Patient recovered from clinically significant toxicities from prior treatment.
Exclusion Criteria:
- Prior treatment with 2 or more prior chemotherapy regimens.
- Concurrent treatment with an estrogen-containing agent including diethylstilbestrol (DES).
- Prior flutamide (Eulexin) within past 4 weeks, prior bicalutamide (Casodex) within past 6 weeks, or prior nilutamide (Nilandron) within past 6 weeks.
- Prior strontium or samarium or other radioisotope therapy.
- Prior radiation therapy to greater than 25% of the bone marrow (e.g., no whole pelvic irradiation is allowed).
- Uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment.
- Patients with uncontrolled hypertension.
- Pre-existing cardiac, pulmonary, neurologic or other disease that would preclude study participation.
- Documented untreated central nervous system (CNS) metastases. However, patients with treated CNS metastases that have been stable are eligible.
- Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would preclude study participation.
- Active secondary malignancy except non-melanoma skin cancers.
- Known, active infection, or known HIV positive or presence of an AIDS related illness.
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: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
Studiet fullført (Faktiske)
1. desember 2005
Datoer for studieregistrering
Først innsendt
29. april 2004
Først innsendt som oppfylte QC-kriteriene
3. mai 2004
Først lagt ut (Anslag)
4. mai 2004
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ILX651-241
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. .
Kliniske studier på ILX651
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Genzyme, a Sanofi CompanyFullførtMelanomForente stater
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Genzyme, a Sanofi CompanyFullførtIkke-småcellet lungekarsinomForente stater