A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma

ONCOGENEX TECHNOLOGIES INC0 个研究点目标入组 180 人开始时间: 2012年4月3日最近更新: 2015年9月14日

试验速览

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•Histologically documented metastatic or locally inoperable, advanced (T4b, N2, N3 or M1) TCC of the urinary tract (bladder, urethra, ureter and renal pelvis)
•NOTE: Certain mixed histologies that are predominately (= 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires IHC consistent with a TCC origin. Mixed small-cell histologies are excluded.
•Measurable disease according to RECIST 1.1.
•No prior systemic chemotherapy with the following exceptions:
•o Prior history of radiosensitizing single agent therapy is allowed.
•o Prior neoadjuvant and adjuvant systemic chemotherapy are permissible if the interval from the end of therapy to the diagnosis of metastatic disease is at least 12 months.
•Karnofsky performance status =70%.
•Required laboratory values at baseline:
•o ANC = 1.5 x 109 cells/L and platelet count = 125 x 109/L.
•o calculated creatinine clearance =60 mL/minute according to the modified Cockcroft-Gault formula.
•o bilirubin = 1.5 x ULN; AST and ALT = 3.0 x ULN.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•A candidate for potential curative surgery or radiotherapy.
•Intravesicular therapy within the past 3 months.
•Documented brain metastasis or carcinomatous meningitis, treated or untreated.
•Peripheral neuropathy =Grade 2.
•Cerebrovascular accident, myocardial infarction, or pulmonary embolus within 6 months of randomization.
•Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.

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