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

Primary Purpose

Urologic Neoplasms, Metastatic Bladder Cancer, Urinary Tract Neoplasms

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

OGX-427 600 mg

OGX-427 1000 mg

Placebo

Gemcitabine

Cisplatin

Carboplatin

About this trial

This is an interventional treatment trial for Urologic Neoplasms focused on measuring bladder, urinary tract, transitional cell carcinoma, metastatic bladder cancer, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

City of Hope National Medical Center
Cedars-Sinai Medical Center
University of California Los Angeles
USC Norris Comprehensive Cancer Center
Radiological Associates of Sacramento
Yale University
Karmanos Cancer Institute
Siteman Cancer Center, Washington University School of Medicine
Urology Cancer Center and GU Research Network
Montefiore Medical Center, Albert Einstein College of Medicine
Monter Cancer Center
Columbia University Medical Center
Texas Oncology, P.A.
Seattle Cancer Care Alliance
Tom Baker Cancer Center
Cross Cancer Center
British Columbia Cancer Agency
Juravinski Cancer Centre
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health
Princess Margaret Hospital
CHUM-Hospital Notre Dame
Centre Hospitalier Régional et Universitaire - Hôpital
Institute Jean Godinot
Centre Hospitalier Universitaire de Rouen
Centre Hospitalier Universitaire, Institut Gustave Roussy
Centre Paul Papin
Medicale Centre René Gauducheau
Institut Paoli Calmettes
Centre Antoine Lacassagne
Universitätsklinikum Heidelberg
Klinikum Rechts der Isar der Technischen Universität
Johann-Wolfgang-Goethe-Universität Frankfurt
Medizinische Hochschule Hannover
Universitätsklinikum des Saarlandes
Universitätsklinikum Magdeburg A.ö.R.
Universitätsklinikum Dresden
Universitätsklinikum Jena
Universitätsklinikum Mainz
Azienda Ospedaliero-Universitaria Policlinico di Modena
Fondazione IRCCS Policlinico San Matteo Pavia
Unità Operativa di Oncologia Medica
Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
NZOZ Europejskie Centrum Zdrowia Otwock
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Uniwersyteckie Centrum Kliniczne
Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Hospital Clinic I Provincial de Barcelona
Hospital del Mar
Hospital Santa Creu i Sant Pau
Hospital Vall d´Hebrón
Hospital General Universitario Gregorio Marañon
Hospital Universitario 12 de Octubre
Institut Català D'Oncologia, Hospital Duran i Reynals
Instituto Valenciano de Oncología-Fundación (IVO-FINCIVO)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

OGX-427 600 mg

OGX-427 1000 mg

Placebo

Arm Description

Standard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (600 mg)

Standard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (1000 mg)

Standard chemotherapy (gemcitabine and cisplatin) in combination with placebo

Outcomes

Primary Outcome Measures

Overall Survival (OS)

OS is defined as the time from randomization to death from any cause; OS was censored on date of last contact for participants still alive at time of analysis.

Secondary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and Grade 3 or Higher AEs

Treatment-emergent AEs are defined as and AE that occurred after the first dose of study drug up to 30 days after the last dose of study drug. AEs were graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Treatment-emergent AEs could have occurred during loading dose period, chemotherapy period, maintenance period, and treatment period A detailed summary of adverse events is located in the Reported Adverse Event Module.

Number of Participants With ≥ 1 Hematology Abnormality and ≥ 1 Grade 3 or Higher Hematology Abnormality

Number of Participants With ≥ 1 Chemistry Laboratory Abnormality and ≥ 1 Grade 3 or Higher Chemistry Laboratory Abnormality

Number of Participants With ≥ 1 Urinalysis Abnormality and ≥ 1 Grade 3 or Higher Urinalysis Abnormality

Best Objective Tumor Response

Complete Response (CR): Complete disappearance of all measurable and non-measurable disease with no new lesions. Any pathological lymph node (target or non-target) must have a reduction in short axis to < 10 mm). All markers of disease must have normalized. Partial Response (PR): A decrease from baseline of ≥ 30% of the diameter(s) of all target measurable lesions with no unequivocal progression of non-measurable lesions and no new lesions. Stable Disease (SD): Does not qualify for CR, PR, or progression. Disease Progression (PD): If at least one of following criteria is met: 1. Appearance of any new lesion or site of disease. 2. A 20% increase in the sum of the diameter(s) of target measurable lesions over either the smallest sum observed or over baseline if no decrease during therapy has occurred. The sum must also demonstrate an absolute increase of at least 5 mm. 3. Unequivocal progression of non-target lesions alone.

Overall Response Rate (ORR) and Disease Control Rate

Participants were defined as having an "overall response" if their best response is either confirmed CR, confirmed PR, unconfirmed CR or unconfirmed PR. ORR was defined as the percent of participants who had an overall response. Participants were defined as having "disease control" if their best response is confirmed CR, confirmed PR, unconfirmed CR, unconfirmed PR or SD. The disease control rate (DCR) was defined as the percent of participants with disease control. (See "Best Objective Tumor Response" Outcome Measure above for response category definitions.)

Duration of Overall Response Rate

Overall response was defined has having a response of Complete Response (CR) or Partial Response (PR). (See "Best Objective Tumor Response" Outcome Measure above for response category definitions.) Duration of Response is defined as the duration from the first overall response to the first Stable Disease (SD) or Disease Progression (PD), whichever happens first. If no SD or PD, subject is censored at the last tumor assessment (prior to other anti-cancer therapy if applicable).

Progression-free Survival (PFS)

PFS was defined as the time from randomization to the date of disease progression or death, whichever occurred first, before or after treatment discontinuation. For participants still on study and those who remained alive and had not progressed after treatment discontinuation, PFS was censored on the date of the last tumor assessment.

Change From Baseline in Serum Hsp27 levels by End of Treatment

End of Treatment is last non-hemolyzed observation up to last dose + 30 days. Includes unscheduled and additional treatment visits. Hemolyzed samples were excluded.

Change From Baseline in Serum Clusterin Levels by End of Treatment

End of Treatment is last observation up to last dose + 30 days. Includes unscheduled and additional treatment visits.

Change From Baseline in Circulating Tumor Cell (CTC) Count by End of Treatment

End of Treatment is last observation up to last dose + 30 days. Includes unscheduled and additional treatment visits.

Serum OGX-427 Cmax and Trough Levels

only C1 to C6, Ctrough and Cmax - as well report EOT Ctrough

Full Information

NCT ID

NCT01454089

First Posted

October 5, 2011

Last Updated

October 6, 2016

Sponsor

Achieve Life Sciences

Collaborators

PRA Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01454089

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Achieve Life Sciences

Collaborators

PRA Health Sciences

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urologic Neoplasms, Metastatic Bladder Cancer, Urinary Tract Neoplasms

Keywords

bladder, urinary tract, transitional cell carcinoma, metastatic bladder cancer, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

183 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OGX-427 600 mg

Arm Type

Experimental

Arm Description

Standard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (600 mg)

Arm Title

OGX-427 1000 mg

Arm Type

Experimental

Arm Description

Standard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (1000 mg)

Arm Title

Placebo

Arm Type

Active Comparator

Arm Description

Standard chemotherapy (gemcitabine and cisplatin) in combination with placebo

Intervention Type

Drug

Intervention Name(s)

OGX-427 600 mg

Other Intervention Name(s)

apatorsen

Intervention Description

Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (600 mg IV) on Days 1, 8 and 15 of each 21-day cycle.

Intervention Type

Drug

Intervention Name(s)

OGX-427 1000 mg

Other Intervention Name(s)

apatorsen

Intervention Description

Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (1000 mg IV) on Days 1, 8 and 15 of each 21-day cycle.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Patients will receive three loading doses of placebo within a 9-day period. Following the loading dose period, patients will receive weekly placebo infusions (IV) on Days 1, 8 and 15 of each 21-day cycle.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

Patients will receive gemcitabine (1000 mg/m^2) for up to 6 cycles administered IV on Days 1 and 8 of each 21-day cycle following Study Drug infusion. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m^2) will be administered IV for up to 6 cycles. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m^2) is to be administered IV for up to 6 cycles; however, carboplatin could be substituted for cisplatin for some unacceptable toxicities. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS is defined as the time from randomization to death from any cause; OS was censored on date of last contact for participants still alive at time of analysis.

Time Frame

Baseline to date of death by any cause (up to approximately 12 months)

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and Grade 3 or Higher AEs

Description

Time Frame

From initiation of study drug to end of study (up to 8 months)

Title

Number of Participants With ≥ 1 Hematology Abnormality and ≥ 1 Grade 3 or Higher Hematology Abnormality

Time Frame

Screening through End of Study Visit (Within 30 [±7] days following withdrawal of study treatment)

Title

Number of Participants With ≥ 1 Chemistry Laboratory Abnormality and ≥ 1 Grade 3 or Higher Chemistry Laboratory Abnormality

Time Frame

Screening through End of Study Visit (Within 30 [±7] days following withdrawal of study treatment)

Title

Number of Participants With ≥ 1 Urinalysis Abnormality and ≥ 1 Grade 3 or Higher Urinalysis Abnormality

Time Frame

Screening through End of Study Visit (Within 30 [±7] days following withdrawal of study treatment)

Title

Best Objective Tumor Response

Description

Time Frame

Baseline to measured progressive disease (up to approximately 12 months)

Title

Overall Response Rate (ORR) and Disease Control Rate

Description

Time Frame

Baseline to measured progressive disease (up to approximately 12 months)

Title

Duration of Overall Response Rate

Description

Time Frame

Baseline to measured progressive disease (up to approximately 12 months)

Title

Progression-free Survival (PFS)

Description

Time Frame

Baseline to measured progressive disease (up to approximately 12 months)

Title

Change From Baseline in Serum Hsp27 levels by End of Treatment

Description

End of Treatment is last non-hemolyzed observation up to last dose + 30 days. Includes unscheduled and additional treatment visits. Hemolyzed samples were excluded.

Time Frame

Baseline, End of Treatment (up to approximately 12 months)

Title

Change From Baseline in Serum Clusterin Levels by End of Treatment

Description

End of Treatment is last observation up to last dose + 30 days. Includes unscheduled and additional treatment visits.

Time Frame

Baseline, End of Treatment (up to approximately 12 months)

Title

Change From Baseline in Circulating Tumor Cell (CTC) Count by End of Treatment

Description

End of Treatment is last observation up to last dose + 30 days. Includes unscheduled and additional treatment visits.

Time Frame

Baseline, End of Treatment (up to approximately 12 months)

Title

Serum OGX-427 Cmax and Trough Levels

Description

only C1 to C6, Ctrough and Cmax - as well report EOT Ctrough

Time Frame

Cycle 1 Day 1 through Cycle 6 Day 1, End of Treatment (up to approximately 12 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Petrylak, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope National Medical Center

City

Duarte

State/Province

California

Country

United States

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

Country

United States

Facility Name

University of California Los Angeles

City

Los Angeles

State/Province

California

Country

United States

Facility Name

USC Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

Country

United States

Facility Name

Radiological Associates of Sacramento

City

Sacramento

State/Province

California

Country

United States

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

Country

United States

Facility Name

Siteman Cancer Center, Washington University School of Medicine

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

Urology Cancer Center and GU Research Network

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

Montefiore Medical Center, Albert Einstein College of Medicine

City

Bronx

State/Province

New York

Country

United States

Facility Name

Monter Cancer Center

City

Lake Success

State/Province

New York

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

Country

United States

Facility Name

Texas Oncology, P.A.

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Tom Baker Cancer Center

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

Cross Cancer Center

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

British Columbia Cancer Agency

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health

City

Oshawa

State/Province

Ontario

Country

Canada

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

CHUM-Hospital Notre Dame

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Centre Hospitalier Régional et Universitaire - Hôpital

City

Bretonneau Tours

State/Province

Centre

Country

France

Facility Name

Institute Jean Godinot

City

Reims

State/Province

Champagne-Ardenne

Country

France

Facility Name

Centre Hospitalier Universitaire de Rouen

City

Rouen

State/Province

Haute-Normandie

Country

France

Facility Name

Centre Hospitalier Universitaire, Institut Gustave Roussy

City

Villejuif Cedex

State/Province

Ile-de-france

Country

France

Facility Name

Centre Paul Papin

City

Angers Cedex 9

State/Province

Pays De La Loire

Country

France

Facility Name

Medicale Centre René Gauducheau

City

St. Herblain Cedex

State/Province

Pays de la Loire

Country

France

Facility Name

Institut Paoli Calmettes

City

Marseille Cedex 9

State/Province

Provence Alpes Cote D'Azur

Country

France

Facility Name

Centre Antoine Lacassagne

City

Nice

State/Province

Provence Alpes Cote d'Azur

Country

France

Facility Name

Universitätsklinikum Heidelberg

City

Heidelberg

State/Province

Baden-Wuerttemberg

Country

Germany

Facility Name

Klinikum Rechts der Isar der Technischen Universität

City

München

State/Province

Bayern

Country

Germany

Facility Name

Johann-Wolfgang-Goethe-Universität Frankfurt

City

Frankfurt

State/Province

Hessen

Country

Germany

Facility Name

Medizinische Hochschule Hannover

City

Hannover

State/Province

Niedeersachen

Country

Germany

Facility Name

Universitätsklinikum des Saarlandes

City

Homburg

State/Province

Saarland

Country

Germany

Facility Name

Universitätsklinikum Magdeburg A.ö.R.

City

Magdeburg

State/Province

Sachsen-Anhalt

Country

Germany

Facility Name

Universitätsklinikum Dresden

City

Dresden

State/Province

Sachsen

Country

Germany

Facility Name

Universitätsklinikum Jena

City

Jena

State/Province

Thuringen

Country

Germany

Facility Name

Universitätsklinikum Mainz

City

Mainz

Country

Germany

Facility Name

Azienda Ospedaliero-Universitaria Policlinico di Modena

City

Modena

Country

Italy

Facility Name

Fondazione IRCCS Policlinico San Matteo Pavia

City

Pavia

Country

Italy

Facility Name

Unità Operativa di Oncologia Medica

City

Roma

Country

Italy

Facility Name

Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu

City

Wroclaw

State/Province

Dolnoslaskie

Country

Poland

Facility Name

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

City

Bydgoszcz

State/Province

Kujawsko-Pomorskie

Country

Poland

Facility Name

NZOZ Europejskie Centrum Zdrowia Otwock

City

Otwock

State/Province

Mazowieckie

Country

Poland

Facility Name

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

City

Warszawa

State/Province

Mazowieckie

Country

Poland

Facility Name

Uniwersyteckie Centrum Kliniczne

City

Gdansk

State/Province

Pomorskie

Country

Poland

Facility Name

Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

City

Olsztyn

State/Province

Warminski-Mazurskie

Country

Poland

Facility Name

Hospital Clinic I Provincial de Barcelona

City

Barcelona

Country

Spain

Facility Name

Hospital del Mar

City

Barcelona

Country

Spain

Facility Name

Hospital Santa Creu i Sant Pau

City

Barcelona

Country

Spain

Facility Name

Hospital Vall d´Hebrón

City

Barcelona

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

Country

Spain

Facility Name

Institut Català D'Oncologia, Hospital Duran i Reynals

City

Madrid

Country

Spain

Facility Name

Instituto Valenciano de Oncología-Fundación (IVO-FINCIVO)

City

Valencia

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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