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| Sponsored by: |
AstraZeneca |
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00661609 |
Purpose
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 |
|
Bladder Cancer Transitional Cell Bladder Cancer Urethra Cancer Ureter Cancer Renal Pelvis Cancer |
Drug: AZD4877 |
Phase II |
| Genetics Home Reference related topics: | bladder cancer |
| MedlinePlus related topics: | Bladder Cancer Cancer |
| 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: | October 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
AZD4877: Experimental
Single agent AZD4877
|
Drug: AZD4877
IV, 25mg/weekly
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
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Show 34 Study Locations |
| AstraZeneca |
| Principal Investigator: | Gary Hudes, MD | Fox Chase Cancer Center |
More Information
| Responsible Party: | AstraZeneca ( Jeffrey Skolnik, MD/Associate Medical Director ) |
| Study ID Numbers: | D2782C00010 |
| First Received: | April 16, 2008 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00661609 |
| 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 |
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