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Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hoosier Cancer Research Network
Sponsor:
Collaborators:
OncoGenex Technologies
Hoosier Cancer Research Network
Information provided by (Responsible Party):
Noah Hahn, M.D., Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT01780545
First received: January 25, 2013
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

This is a randomized, open-label Phase 2 clinical trial to evaluate whether suppression of Hsp27 (Heat shock protein 27) production using OGX-427, a second-generation antisense oligonucleotide (ASO), in combination with docetaxel can prolong survival time compared to docetaxel alone in participants with locally advanced or metastatic urothelial carcinoma (UC) that are relapsed or refractory after receiving a platinum-containing regimen.


Condition Intervention Phase
Bladder Cancer
Urothelial Carcinoma
Drug: OGX-427
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Borealis-2 Clinical Trial: A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Combination With OGX-427 in Patients With Relapsed or Refractory Metastatic Urothelial Carcinoma After Receiving a Platinum-containing Regimen: Hoosier Cancer Research Network GU12-160

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
    To determine whether docetaxel administered in combination with OGX-427 provides a survival benefit compared to docetaxel alone.


Secondary Outcome Measures:
  • Safety and Toxicity of Regimen [ Time Frame: Every week ] [ Designated as safety issue: Yes ]
    To compare the safety and toxicity of OGX-427 in combination with docetaxel to that of docetaxel alone. Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  • Overall Response Rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
    To compare overall response rate (ORR) between the treatment arms.

  • Serum Levels of Hsp27 and Other Proteins [ Time Frame: Each cycle ] [ Designated as safety issue: No ]
    To evaluate the effect of therapy with docetaxel and OGX-427 on serum Hsp27 levels and other serum proteins and explore their relation with clinical outcomes.

  • Hsp27 Expression in Archival Tissue [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]
    To evaluate the association of urothelial carcinoma expression of Hsp27 measured by immunohistochemistry (IHC) in archival tissue with clinical outcomes.

  • Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity [ Time Frame: Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5 ] [ Designated as safety issue: No ]
    To evaluate the effect of therapy with docetaxel and OGX-427 on peripheral blood circulating tumor cells (CTCs) enumeration and expression of Hsp27 and other relevant proteins via immunoflourescence, and levels of telomerase by quantitative polymerase chain reaction (PCR), and explore their relation with clinical outcomes.


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm: Arm A
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle.
Drug: OGX-427

Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.

Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease assessments following at least 2 cycles of chemotherapy. Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.

Drug: Docetaxel

For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.

Active Comparator: Control Arm: Arm B
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Drug: Docetaxel

For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.


  Hide Detailed Description

Detailed Description:

OUTLINE: This is a multi-center study.

Eligible patients will be stratified based on time from prior systemic chemotherapy (< 3 vs ≥ 3 months) and Bellmunt prognostic factors criteria, which include Eastern Cooperative Oncology Group (ECOG) performance status >0, hemoglobin <10g/dL, and presence of liver metastases (0 versus 1-3 risk factors). Within the strata, participants will be randomly assigned with equal probability to either the investigational arm (Arm A: docetaxel + OGX-427) or the control arm (Arm B: docetaxel alone).

INVESTIGATIONAL ARM OGX-427 + DOCETAXEL (Arm A):

LOADING DOSE PERIOD:

Participants randomized onto the investigational arm (Arm A) will receive OGX-427 beginning with a loading dose period prior to the initiation of docetaxel treatment. The first dose of OGX-427 for the loading dose period must be administered within 5 working days of registration and randomization.

During the loading dose period, participants will receive three separate administrations of 600 mg OGX-427 intravenously (IV) (days -9 to -1). There must be at least one "non-infusion" day between each administration of OGX-427 (i.e., every other day) during the loading dose period and between the third loading dose of OGX-427 and day 1 of cycle 1. There should be no more than 7 days between the last loading dose and day 1 of cycle 1.

TREATMENT PERIOD:

During the treatment period, participants randomized to this arm will receive:

  • OGX-427 600 mg IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
  • Docetaxel (75 mg/M2) IV on day 1 of each 21-day cycle. Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

OGX-427 MAINTENANCE:

Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy for participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease assessments following at least 2 cycles of chemotherapy. Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.

CONTROL ARM - DOCETAXEL ALONE (Arm B):

TREATMENT PERIOD:

During the treatment period, participants randomized to this arm will receive:

- Docetaxel (75 mg/M2) IV on day 1 of each 21-day cycle. The first dose of docetaxel must be administered within 5 working days of registration and randomization. Participants will continue to receive docetaxel on day 1 of each 21-day cycle until disease progression, unacceptable toxicity related to docetaxel, voluntary patient withdrawal, or a maximum of 10 docetaxel cycles.

FOLLOW-UP FOR BOTH ARMS:

Imaging studies will be performed every 6 weeks (i.e., after completion of cycles 2, 4, 6, 8 and 10) until disease progression and with any sign or symptom of new or worsening disease; computed tomography scan (CT) of chest/abdomen/pelvis is preferred but magnetic resonance imaging scan(MRI) is acceptable, especially for participants with increased risk of contrast-related nephropathy or other contraindications. For Arm A, scans will be performed every 2 cycles (6 weeks) +/1 week during the 21-day cycles of docetaxel administration and every 6 weeks during maintenance OGX-427 administration until disease progression; for Arm B, scans will be performed every 6 weeks during the 21-day cycles of docetaxel administration until disease progression. All scans should be completed before the subsequent cycle is scheduled to begin. Bone scans will be repeated, if positive at baseline, every 6 weeks during the first 4 cycles of treatment (i.e., at the end of cycles 2 and 4) and then every 12 weeks thereafter until disease progression (i.e., at the end of cycle 8, at end of treatment, and during maintenance with OGX-427 [Arm A only]).

All participants will have an End of Treatment (EOT) visit when they discontinue study treatment. All participants will be followed until documented disease progression.

Once disease progression is documented, participants will enter a survival follow-up period. All participants must be followed for survival as the primary endpoint. During the survival follow-up period, data will be collected every three months regarding further cancer therapy, secondary malignancy, and survival status.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Life Expectancy: Greater than 3 months

Hematopoietic:

  • Absolute neutrophil count(ANC)≥ 1,500/mcL
  • Hemoglobin ≥ 8 g/dL
  • Platelets ≥ 100,000/mcL

Hepatic:

  • Bilirubin ≤ 1.1 x upper limit of normal (ULN) (≤ 2.0 x ULN if secondary to Gilbert's disease)
  • Aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT)/alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) ≤ 1.5 X institutional ULN

Renal:

  • Serum creatinine ≤ 1.5 x ULN

Cardiac:

  • Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or myocardial infarction within 3 months of randomization.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologically documented metastatic or locally inoperable advanced urothelial carcinoma (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3, or M1 disease. NOTE: Aberrant differentiation such as squamous, glandular (adenocarcinoma), and micropapillary are eligible unless the tumor is considered a pure histological variant according to the pathology report. Participants with small cell histology are not eligible.
  • Participants must have 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 RECIST v1.1 criteria.
  • Participants must have received prior systemic chemotherapy treatment for metastatic urothelial carcinoma. NOTE: Up to 2 prior systemic chemotherapeutic regimens given in the metastatic disease setting for urothelial carcinoma are allowed.
  • Specifically, subjects must meet one or more of the following criteria:

    1. Progression during or after treatment with a regimen that includes a platinum salt (e.g., carboplatin or cisplatin) OR
    2. Disease recurrence within one year after neoadjuvant or adjuvant platinum-based systemic chemotherapy, measured from the date of last dose of chemotherapy or surgery until the day the informed consent is signed
  • Participants must be ≥18 years since no dosing or adverse event data are currently available on the use of OGX-427 in participants <18 years of age.
  • Minimum of 21 days have elapsed since prior major surgery, with recovery from any adverse events.
  • Minimum of 14 days have elapsed since any prior radiation therapy, with recovery from any adverse events.
  • The effects of OGX-427 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • History of treatment with docetaxel in any setting. Participants treated with prior paclitaxel are eligible.
  • Prior enrollment in the OncoGenex Phase 2 Study OGX-427-02.
  • Participants may not be receiving other investigational agents.
  • Participants with known brain or spinal cord metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of central nervous system (CNS) disease.
  • History of allergic reactions or severe hypersensitivity reactions to drugs formulated with polysorbate 80 or antisense oligonucleotides.
  • Peripheral neuropathy ≥Grade 2.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Cerebrovascular accident or pulmonary embolus within 3 months of randomization.
  • Pregnant women and breast feeding women are excluded from this study because of the risk to a fetus due to docetaxel chemotherapy and OGX-427 systemic treatment (fertility toxicology studies have not been completed for OGX-427).
  • Active second malignancy (except non-melanomatous skin cancer or incidental prostate cancer found on cystectomy): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780545

Contacts
Contact: Costantine Albany, M.D. 3179212050 ggould@hoosiercancer.org
Contact: Cynthia Burkhardt, R.N. 3179212050 ggould@hoosiercancer.org

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Hematology Oncology Clinic at Medical West Recruiting
Birmingham, Alabama, United States, 35294
Contact: Guru Sonpavde, M.D.       sonpavde@uab.edu   
Contact: J Lynn Merritt    205.975.2028    jlynnrn@uab.edu   
United States, California
City of Hope: Duarte Recruiting
Duarte, California, United States, 91010
Contact: Sumanta Pal, M.D.       spal@coh.org   
Contact: Dorie Cook    626.256.4673 ext 61578    dcook@coh.org   
City of Hope: Antelope Valley Recruiting
Lancaster, California, United States, 93534
Contact: Sumanta Pal, M.D.       spal@coh.org   
Contact: Dorie Cook    626.256.4673 ext 61578    dcook@coh.org   
UCLA: Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Steven Wong, M.D.       sgwong@mednet.ucla.edu   
Contact: Ross Mar Divinagracia    310.794.3448    rossmar@mednet.ucla.edu   
USC: Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90089
Contact: David Quinn, M.D.       diquinn@usc.edu   
Contact: Zeno Ashai    323.865.0454    zeno.ashai@med.usc.edu   
United States, Indiana
IU Health Goshen Hospital Recruiting
Goshen, Indiana, United States, 46527
Contact: Alex Starodub, M.D.    574-535-2886    astarodub@iuhealth.org   
Contact: Vanessa De Pue    574.364.2649    vdepue@iuhealth.org   
Indiana University Melvin & Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Costantine Albany, M.D.       calbany@iu.edu   
Contact: Rhoda Lohman    317-278-4840    rloman@iupui.edu   
IU Health Central Indiana Cancer Centers Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Bamidele Adensunloye, M.D.    317-859-5500    badesunloye@IUHealth.org   
Contact: Ahran Lee    317-678-2738    alee4@iuhealth.org   
IU Health at Ball Memorial Hospital Recruiting
Muncie, Indiana, United States, 47303
Contact: William Fisher, M.D.    765-281-2174    wfisher1@iuhealth.org   
Contact: Angie Patterson, R.N.    765-2751-5849    apatterson2@iuhealth.org   
United States, Maryland
University of Maryland: Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Arif Hussain, M.D.    410-328-7226    ahussain@som.umaryland.edu   
Contact: Michelle Besche    410.328.8610    mbesche@umm.edu   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Toni Choueiri, MD    617-632-4524    Toni_Choueiri@dfci.harvard.edu   
Contact: Bon Lam    617-632-5261    BonM_Lam@dfci.harvard.edu   
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ajjai Alva, MB, BS    734-647-8903    ajjai@med.umich.edu   
Contact: Sabrina Hargrove    734-936-8587    sgomes@med.umich.edu   
United States, Missouri
Siteman Cancer Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: Joel Picus, M.D.    314-747-1367      
Contact: Christopher Grant    314-747-3575    cgrant@dom.wustl.edu   
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68114
Contact: Ralph Hauke, M.D.    402-354-8124    rhauke@nebraskacancer.com   
Contact: Gladys Pierce    402-354-5129    gladys.pierce@nmhs.org   
United States, New Hampshire
Dartmouth-Hitchcock Medical Center: Norris Cotton Cancer Center Recruiting
Manchester, New Hampshire, United States, 03102
Contact: Sergey Devitskiy, M.D.    603-650-5534    Sergey.Devitskiy@hitchcock.org   
Contact: Neal Wilson    (603) 653-9054    neal.a.wilson@hitchcock.org   
United States, New Jersey
Memorial Sloan-Kettering Cancer Center: Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Jonathan Rosenberg, MD    646-422-4461    rosenbj1@mskcc.org   
Contact: Mariel Boyd    646.227.7186    boydm@mskcc.org   
John Theurer Cancer Center: Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Robert Alter, M    551-996-5072    ralter@hackensackumc.org   
Contact: Jane Hayes    551.996.5831    jhayes@hackensackumc.org   
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Mark Stein, M.D.       steinmn@cinj.rutgers.edu   
Contact: Kaveri Mamania    732.235.9837    mamanikb@cinj.rutgers.edu   
United States, New Mexico
University of New Mexico Cancer Center: Albuquerque Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Richard Lauer, M.D.       rlauer@salud.unm.edu   
Contact: Rebecca Myers    575.556.6545    rmyers-brito@salud.umn.edu   
University of New Mexico Cancer Center: Las Cruces Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: William Adler, M.D.    575-521-1554    William.Adler@lpnt.net   
Contact: Kim Hoffman       Kim.Hoffman@lpnt.net   
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roberto Pili, M.D.       roberto.pili@roswellpark.org   
Contact: Eileen Healy, 0    716.845.8910    eileen.healy@roswellpark.org   
Memorial Sloan-Kettering Cancer Center: Commack Recruiting
Commack, New York, United States, 11725
Contact: Jonathan Rosenberg, MD    646-422-4461    rosenbj1@mskcc.org   
Contact: Mariel Boyd    646.227.7186    boydm@mskcc.org   
Memorial Sloan-Kettering Cancer Center: Main Campus Recruiting
New York, New York, United States, 10065
Contact: Jonathan Rosenberg, MD    646-422-4461    rosenbj1@mskcc.org   
Contact: Ilana Garcia-Grossman    646-227-7186    garciagi@mskcc.org   
New York University Clinical Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Arjun Balar, M.D.    212-731-5820    arjun.balar@nyumc.org   
Contact: Sarah Torneten    212.263.4424    sarah.torneten@nyumc.org   
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Elizabeth Guancial, M.D.       Elizabeth_Guancial@urmc.rochester.edu   
Contact: Melissa Worman    585.275.4583    melissa_worman@urmc.rochester.edu   
Memorial Sloan-Kettering Cancer Center: Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Jonathan Rosenberg, MD    646-422-4461    rosenbj1@mskcc.org   
Contact: Mariel Boyd    646.227.7186    boydm@mskcc.org   
Memorial Sloan-Kettering Cancer Center: Sleepy Hollow Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Jonathan Rosenberg, MD    646-422-4661    rosenbj1@mskcc.org   
Contact: Mariel Boyd    646.227.7186    boydm@mskcc.org   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rob Dreicer, M.D.    216-445-2360      
Contact: Krista Zaharewick    216-444-2748    zaharek@ccf.org   
University Hospitals Seidman Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Christopher Hoimes, D.O.    216-844-3951    cjh122@case.edu   
Contact: Janette Gortz    216-844-1545    janette.gortz@uhhospitals.org   
Lake Health: University Hospitals Seidman Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Christopher Hoimes, D.O.    216-844-3951    cjh122@case.edu   
Contact: Janette Gortz    216.844.1545    janette.gortz@uhhospitals.org   
UHHS Chagrin Highlands: Seidman Cancer Center Recruiting
Orange Village, Ohio, United States, 44122
Contact: Christopher Hoimes, D.O.    216-844-3951    cjh122@case.edu   
Contact: Janette Gortz    216.844.1545    janette.gortz@uhhospitals.org   
United States, Pennsylvania
Thomas Jefferson University: Kimmel Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jean Hoffman-Censits, M.D.    215-955-8874    jean.hoffman-censits@jefferson.edu   
Contact: Monica Byrnes    215.503.0552    monica.byrnes@jefferson.edu   
United States, South Carolina
MUSC Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Harry Drabkin, M.D.    843-792-9007    drabkin@musc.edu   
Contact: Seth Price    843-792-8625    pricesr@musc.edu   
United States, Wisconsin
Froedtert & Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: John Burfeind, M.D.       jburfeind@mcw.edu   
Contact: Kristen Lemke    414.805.4627    klemke@mcw.edu   
Sponsors and Collaborators
Noah Hahn, M.D.
OncoGenex Technologies
Hoosier Cancer Research Network
Investigators
Study Chair: Noah Hahn, M.D. Hoosier Cancer Research Network
  More Information

Additional Information:
Publications:
Jonathan E. Rosenberg, Noah M. Hahn, Meredith M. Regan, Cindy Jacobs, Patricia S. Stewart, Toni K. Choueiri. The Borealis-2 clinical trial: A randomized phase II study of OGX-427 plus docetaxel versus docetaxel alone in relapsed/refractory metastatic urothelial cancer. J Clin Oncol 31, 2013 (suppl; abstr TPS4588^) http://abstracts2.asco.org/AbstView_132_114639.html

Responsible Party: Noah Hahn, M.D., Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01780545     History of Changes
Other Study ID Numbers: GU12-160
Study First Received: January 25, 2013
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoosier Cancer Research Network:
OGX-427
Docetaxel

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014