Lauren Harshman
A Phase II Study of AZD4877 (a Novel Anti-Mitotic Agent) in Advanced Bladder Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: AZD4877
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
- TNM Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
- Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting.
- Ambulatory and capable of all selfcare more than 50% of waking hours
Key Exclusion Criteria:
- Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication; 6 weeks if prior systemic mitomycin, nitrosourea, or suramin.
- Inadequate bone marrow reserve
- Inadequate liver function in the presence of liver metastases
- Impaired renal function
Additional Study Details
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 CancerAnticipated start date:
10/10/2008Lead Sponsor:
AstraZenecaInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Objective Response Rate in patients with recurrent advanced urothelial cancer receiving 25 mg of AZD4877 once weekly, with a response of complete or partial as assessed by RECIST criteria
Secondary Outcomes:
- To describe the efficacy of AZD4877 in terms of disease control rate
- To describe the efficacy of AZD4877 in terms of duration of objective tumor response
- To describe the efficacy of AZD4877 in terms of progression-free survival and overall survival
Total Number to be Enrolled:
50Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- BLDR0009
- D2782C00010
- NCT00661609
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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