- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01155791
Phase I Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer
A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
California
-
Stanford, California, Forente stater, 94305
- Stanford University School of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
Castration-resistant prostate cancer requires the following 3 criteria:
- Failure of first line bilateral orchiectomy or therapy with an LHRH agonist,
- A rising PSA on 3 consecutive occasions at least 1 week apart (but not limited to the 30 day screening period), AND
- A castrate level of testosterone (<50ng/dL)
- PSA doubling time (PSADT) > 1 months
- Failure on docetaxel chemotherapy as defined by a rising PSA .
- A minimum PSA of 2 ng/mL
- Age >=18 years
- Life expectancy greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Karnofsky performance status >=80%
- Bone metastases will be allowed
- The subject has a QTcB (Bazett corrected) or QTcF (Frederica corrected) < 470 msec.
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to stay on docetaxel chemotherapy despite rising PSA level.
Exclusion Criteria:1. Radiotherapy for prostate cancer within 28 days prior to Day 1.
2. More than 1 prior chemotherapy
3. Inadequate organ function, as evidenced by any of the following at screening:
- Absolute neutrophil count (ANC) < 1500/uL
- Platelet count <= 100 x 10^9/L
- Total bilirubin >= ULN
- AST, and/or ALT > 1.5 x the upper limit of normal (ULN) with a concomitant alkaline phosphastase >2.5 X ULN
- Serum creatinine > 2.0 mg/dL
Hemoglobin < 9 g/dL
4. Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 3 months after completion of the study treatment.
5. History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancer
6. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
7. Known or prior treated brain metastases.
8. History of hypersensitivity to docetaxel
9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure ,unstable angina pectoris, cardiac arrhythmia, significant vascular disease (e.g. aortic aneurysm, aortic dissection), symptomatic peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements.
10. History of myocardial infarction or unstable angina within 6 months prior to study enrollment
11. History of stroke or transient ischemic attack within 6 months prior to study enrollment 12. The subject is known to be positive for the human immunodeficiency virus (HIV) and is receiving antiretroviral 12. Willingness to stay on docetaxel chemotherapy despite rising PSA level.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: combination sodium selenite and docetaxel
|
IV 75 mg/m2
IV dosage varies
5mg, orally
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the safety and tolerability of the combination sodium selenite and docetaxel after 4 cycles of combination therapy using the NCI Common Toxicity Criteria v3.0 grading system for adverse events
Tidsramme: after 4 cycles of combination therapy
|
after 4 cycles of combination therapy
|
To determine the maximum tolerated dose (MTD)
Tidsramme: 1 cycle
|
1 cycle
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Genitale neoplasmer, hanner
- Prostata sykdommer
- Neoplastiske prosesser
- Prostatiske neoplasmer
- Neoplasma Metastase
- Urologiske neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Docetaxel
- Prednison
Andre studie-ID-numre
- PROS0033
- SU-05122010-6002 (Annen identifikator: Stanford University)
- 17356 (Annen identifikator: REB)
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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