- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00907959
A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
A Phase 2 Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Mary Tagliaferri, MD
- Telefonnummer: 5106012000
- E-post: mary@bionovo.com
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77030
- M.D. Anderson Cancer Center
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Ta kontakt med:
- Banu Arun, MD
- Telefonnummer: 713-792-2817
- E-post: barun@mdanderson.org
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Hovedetterforsker:
- Banu Arun, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Women 18 years or older.
- Histologically confirmed diagnosis of breast cancer based on pathology report of primary, regional or metastatic breast cancer.
- Clinical evidence of metastatic (stage IV) involvement other than bone only metastasis based on the investigator's clinical and/or radiographic findings.
- Availability of estrogen receptor and progesterone receptor status measured on biopsy tissue. (Status on the most recent biopsy where ER/PR status was documented will be used to determine hormone receptor status for stratification).
- At least one measurable disease site defined by RECIST criteria, with measurement made within 30 days of beginning study therapy. (Non-measurable disease includes bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions. For lesions in a previously irradiated field, the radiated lesion cannot be assessed as a measurable lesion unless growth of that lesion has been documented after radiation).
- No more than 2 prior cytotoxic regimens administered for metastatic breast cancer. (Participants may have received any number of exogenous hormone therapies for Stage IV disease and/or adjuvant therapy).
- Life expectancy of >12 weeks.
- Eastern Cooperative Oncology Group performance status <2.
Women of child bearing potential must agree to use two adequate methods of contraception or abstain from sexual intercourse during study treatment. Acceptable methods of contraception are as follows:
- Intrauterine device (IUD)
- Hormonal birth control
- Tubal ligation
- Partner's vasectomy
- Latex condom
- Diaphragm
- Cervical cap
- Adequate organ and marrow function measured within 14 days of study treatment as defined below:
Absolute neutrophil count >1,500 cells/mm3 Platelets >100,000 cells/mm3 Hemoglobin >10 g/dL Total bilirubin <1.5 mg/dL AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal or <5 X normal with documented liver metastasis Alkaline Phosphatase <3 X institutional upper limit of normal or <5 X normal with documented liver or bone metastasis Serum creatinine <1.5 mg/dL or Creatinine clearance >60 mL/min/1.73 m2 for participants with serum creatinine levels above institutional normal.
Exclusion Criteria:
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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The primary outcomes of the Phase 2 trial will be safety and toxicity as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and tumor response rate defined by new RECIST criteria 1.1.
Tidsramme: Monthly
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Monthly
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BZL-101-003
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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BionovoFullført