A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Urologic Neoplasms, Metastatic Bladder Cancer, Urinary Tract Neoplasms

In brief

The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.

Key facts

Study ID

NCT01454089

Run by

Achieve Life Sciences

People needed

183

Starts

2011-10-01

Expected to finish

2014-11-01

Last updated by the study team

2016-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years at the time of consent
• Histologically documented metastatic or locally inoperable advanced transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3 or M1 disease) NOTE: Certain mixed histologies that are predominately (≥ 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires immunohistochemistry (IHC) consistent with a TCC origin. Mixed small-cell histologies are excluded
• Measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• No prior systemic chemotherapy with the following exceptions:
• Prior use of radiosensitizing single agent therapy is allowed
• Prior neoadjuvant and adjuvant chemotherapy may be allowed
• Minimum of 21 days since prior major surgery or radiation therapy
• Karnofsky performance status ≥ 70%
• Required laboratory values at baseline:
• absolute neutrophil count (ANC) ≥ 1.5 x 10\^9 cells/L
• platelet count ≥ 125 x 10\^9/L
• calculated creatinine clearance ≥ 60 mL/minute
• bilirubin ≤ 1.5 x upper limit of normal (ULN; ≤ 2.5 x ULN if secondary to Gilbert's disease)
• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
• If of child-bearing potential, willing to use contraceptives
• Willing to give written informed consent

You may not qualify if…

• A candidate for potential curative surgery or radiotherapy
• Intravesical therapy within the last 3 months
• Documented brain metastasis or carcinomatous meningitis, treated or untreated. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of central nervous system (CNS) disease.
• Peripheral neuropathy ≥ Grade 2
• Known serious hypersensitivity to gemcitabine, cisplatin or carboplatin
• Current serious, uncontrolled medical condition such as congestive heart failure, angina, hypertension, arrhythmia, diabetes mellitus, infection, etc. or any condition such as a psychiatric illness which in the opinion of the investigator would make the patient unacceptable for the protocol
• 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
• Pregnant or nursing (must have a negative serum or urine pregnancy test within 72 hours prior to randomization)
• Participating in a concurrent clinical trial of an experimental drug, vaccine or device. Participation in an observational study is allowed

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Radiological Associates of Sacramento — Sacramento, California, United States
• Yale University — New Haven, Connecticut, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Siteman Cancer Center, Washington University School of Medicine — St Louis, Missouri, United States
• Urology Cancer Center and GU Research Network — Omaha, Nebraska, United States
• Monter Cancer Center — Lake Success, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center, Albert Einstein College of Medicine — The Bronx, New York, United States
• Texas Oncology, P.A. — Dallas, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Tom Baker Cancer Center — Calgary, Alberta, Canada
• Cross Cancer Center — Edmonton, Alberta, Canada
• British Columbia Cancer Agency — Vancouver, British Columbia, Canada
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health — Oshawa, Ontario, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• CHUM-Hospital Notre Dame — Montreal, Quebec, Canada
• Centre Hospitalier Régional et Universitaire - Hôpital — Bretonneau Tours, Centre-Val de Loire, France
• Institute Jean Godinot — Reims, Champagne-Ardenne, France
• Centre Hospitalier Universitaire de Rouen — Rouen, Haute-Normandie, France
• Centre Paul Papin — Angers, Pays de la Loire Region, France
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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