Há um Clinical Trial que está sendo iniciado, chamado Ready, para pacientes com cânceres muito avançados, necessitando tratamento quimioterápico.
A descrição, que inclui os critérios de inclusão e de exclusão vão a seguir. Infelizmente, não tenho tempo para traduzir.
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The READY trial is a clinical research trial of an investigational drug for metastatic prostate cancer.
The goal of the READY trial is to evaluate the safety and efficacy of the investigational drug (dasatinib) in combination with the standard of care (docetaxel) vs docetaxel alone in patients with metastatic prostate cancer.
The READY clinical research trial is currently enrolling participants. Approximately 1,650 men are expected to participate in the trial at more than 175 sites globally.
Dasatinib, a multi-kinase inhibitor, is being evaluated for clinical benefit in patients with prostate cancer. The READY Trial is comparing the effects of dasatinib when added to a standard of care regimen of docetaxel and prednisone in 1,380 patients with metastatic castration-resistant prostate cancer (CRPC).
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer
The purpose of this study is to determine whether overall survival can be prolonged in patients with metastatic CRPC who receive dasatinib in addition to a standard of care regimen of docetaxel and prednisone.
• Overall survival
• Rate of change from baseline in urinary N-telopeptide
• Time to first skeletal related event
• Rate of change from baseline in pain intensity
• Time to prostate specific antigen (PSA) progression
• Safety and tolerability
• Rate of objective tumor response by modified RECIST criteria (for subjects with measurable disease at baseline)
• Rate of stable disease by bone scan/imaging at 24 weeks
Key Inclusion Criteria:
• Histologically diagnosed metastatic prostate cancer
• Evidence of metastatic disease (by either CT, MRI, bone scan or skeletal survey)
• Evidence of progression (by either rising PSA, nodal/visceral disease, bone scan/imaging, or local recurrence in the prostate or prostate bed)
• Maintenance of serum testosterone < 50 ng/dL
• ECOG Performance Status 0, 1, or 2
Key Exclusion Criteria:
• Prior or ongoing cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine
• Currently experiencing pleural or pericardial effusion
• Clinically significant cardiovascular disease
• Symptomatic brain or leptomeningeal metastases
• Currently active second malignancy