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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00661609 |
The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer
Condition | Intervention | Phase |
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Bladder Cancer Transitional Cell Bladder Cancer Urethra Cancer Ureter Cancer Renal Pelvis Cancer |
Drug: AZD4877 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II, Single Arm, Single Agent, Multicentre, Adaptive 2-Stage Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD4877 Administered Weekly in Patients With Recurrent Advanced Urothelial Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AZD4877: Experimental
Single agent AZD4877
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Drug: AZD4877
IV, 25mg/weekly
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Gary Hudes, MD | Fox Chase Cancer Center |
Responsible Party: | AstraZeneca ( Jeffrey Skolnik, MD/Associate Medical Director ) |
Study ID Numbers: | D2782C00010 |
Study First Received: | April 16, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00661609 History of Changes |
Health Authority: | Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; France: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Spain: Ministry of Health |
Anti-mitotic Eg5 Inhibitor Kinesin Spindle Protein Inhibitor Urothelial Cancer Bladder Cancer Renal Pelvis Cancer |
Urethra Cancer Ureter Cancer Recurrent Advanced Stage IV |
Urinary Tract Neoplasm Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Antimitotic Agents Urologic Neoplasms |
Recurrence Urologic Diseases Urethral Cancer Urethral Neoplasms Bladder Neoplasm Ureteral Neoplasms Pelvic Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Antimitotic Agents Urologic Neoplasms |
Pharmacologic Actions Neoplasms Neoplasms by Site Urologic Diseases Therapeutic Uses Urethral Neoplasms Urethral Diseases Ureteral Neoplasms Pelvic Neoplasms |