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Spots Global Cancer Trial Database for A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer

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Trial Identification

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

Official Title: 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

Study ID: NCT01454089

Study Description

Brief Summary: 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.

Detailed Description: Following 3 loading doses, participants receive chemotherapy and study drug on a 21-day cycle during the Treatment Period (Chemotherapy Period) until disease progression, completion of 6 cycles, toxicity or voluntary participant withdrawal. Participants who do not have documented disease progression and have completed a minimum of four cycles of chemotherapy continue to receive weekly Study Drug maintenance therapy during the Maintenance Period until disease progression or the participant fulfills one of the other reasons for withdrawal from protocol treatment, unless they have been discontinued from protocol treatment for unacceptable toxicity related to study drug. All participants have an End of Treatment (EOT) visit when they are withdrawn from all study treatment (chemotherapy and maintenance). All participants are followed until documented disease progression. Once disease progression is documented, participants enter a Survival Follow-up Period during which data are collected regarding further cancer therapy, secondary malignancy, and survival status.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope National Medical Center, Duarte, California, United States

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

Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, United States

Monter Cancer Center, Lake Success, New York, United States

Columbia University Medical Center, New York, 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, France

Institute Jean Godinot, Reims, Champagne-Ardenne, France

Centre Hospitalier Universitaire de Rouen, Rouen, Haute-Normandie, France

Centre Hospitalier Universitaire, Institut Gustave Roussy, Villejuif Cedex, Ile-de-france, France

Centre Paul Papin, Angers Cedex 9, Pays De La Loire, France

Medicale Centre René Gauducheau, St. Herblain Cedex, Pays de la Loire, France

Institut Paoli Calmettes, Marseille Cedex 9, Provence Alpes Cote D'Azur, France

Centre Antoine Lacassagne, Nice, Provence Alpes Cote d'Azur, France

Universitätsklinikum Heidelberg, Heidelberg, Baden-Wuerttemberg, Germany

Klinikum Rechts der Isar der Technischen Universität, München, Bayern, Germany

Johann-Wolfgang-Goethe-Universität Frankfurt, Frankfurt, Hessen, Germany

Medizinische Hochschule Hannover, Hannover, Niedeersachen, Germany

Universitätsklinikum des Saarlandes, Homburg, Saarland, Germany

Universitätsklinikum Magdeburg A.ö.R., Magdeburg, Sachsen-Anhalt, Germany

Universitätsklinikum Dresden, Dresden, Sachsen, Germany

Universitätsklinikum Jena, Jena, Thuringen, Germany

Universitätsklinikum Mainz, Mainz, , Germany

Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, , Italy

Fondazione IRCCS Policlinico San Matteo Pavia, Pavia, , Italy

Unità Operativa di Oncologia Medica, Roma, , Italy

Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, Wroclaw, Dolnoslaskie, Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz, Kujawsko-Pomorskie, Poland

NZOZ Europejskie Centrum Zdrowia Otwock, Otwock, Mazowieckie, Poland

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Warszawa, Mazowieckie, Poland

Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland

Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, Warminski-Mazurskie, Poland

Hospital Clinic I Provincial de Barcelona, Barcelona, , Spain

Hospital del Mar, Barcelona, , Spain

Hospital Santa Creu i Sant Pau, Barcelona, , Spain

Hospital Vall d´Hebrón, Barcelona, , Spain

Hospital General Universitario Gregorio Marañon, Madrid, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Institut Català D'Oncologia, Hospital Duran i Reynals, Madrid, , Spain

Instituto Valenciano de Oncología-Fundación (IVO-FINCIVO), Valencia, , Spain

Contact Details

Name: Daniel Petrylak, MD

Affiliation: Columbia University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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