- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00103428
Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer
A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer
V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in metastatic hormone-refractory patients who have not received chemotherapy.
All patients will receive docetaxel. In the dose escalation phase of the study, patients will receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2 portion of this study, additional patients will be added at the maximum tolerated dose that is determined in Phase 1.
Studieoversigt
Undersøgelsestype
Tilmelding
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Mary Crowley Medical Research Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy)
- Detectable metastases by bone scan, and/or CT scan, and/or MRI, and/or CXR
- ECOG performance status 0-1
Exclusion Criteria:
- Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- History of deep vein thrombosis or pulmonary embolus
- Patients taking anticoagulants (such as coumadin or Heparin). The use of aspirin while on study is acceptable.
- History of a bleeding disorder or recent clinically significant bleeding
- Seropositive for HIV
- History of Hepatitis B, Hepatitis C, or chronic liver disease
- Prior gene therapy or immunotherapy
- Prior chemotherapy for prostate cancer
- Radiation therapy within 4 weeks of the first treatment.
- History of myocardial infarction within 6 months of the first treatment
- History of cerebrovascular accident
- History of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
- Evidence of active prostatitis
- Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Metastatic hormone refractory prostate cancer
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- V-0039
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Kliniske forsøg med CG7870
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Cell GenesysAfsluttet