The trial is designed to determine the efficacy of OGX-427 Vs placebo in combination with Gemcitabine and Cisplatin in patients with Urinary tract cancer.

• Conditions: Metastatic or locally inoperable, advanced (T4b, N2, N3 or M1)transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra,ureter and renal pelvis); MedDRA version: 14.1Level: PTClassification code 10005084Term: Bladder transitional cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002424-41-IT
• Lead Sponsor: ONCOGENEX TECHNOLOGIES INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-03
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified