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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Bladder Cancer, Urethra Cancer, Ureter Cancer, Renal Pelvis Cancer

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Trial Information

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


Inclusion Criteria:



- Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or
urethra).

- Tumor, Node, Metastasis (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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)

Outcome Description:

Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).

Outcome Time Frame:

8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)

Safety Issue:

No

Principal Investigator

Gary Hudes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

Canada: Health Canada

Study ID:

D2782C00010

NCT ID:

NCT00661609

Start Date:

May 2008

Completion Date:

December 2009

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Bladder Cancer
  • Urethra Cancer
  • Ureter Cancer
  • Renal Pelvis Cancer
  • Anti-mitotic
  • Eg5 Inhibitor
  • Kinesin Spindle Protein Inhibitor
  • Urothelial Cancer
  • Bladder Cancer
  • Renal Pelvis Cancer
  • Urethra Cancer
  • Ureter Cancer
  • Recurrent
  • Advanced
  • Stage IV
  • Urinary Bladder Neoplasms
  • Kidney Neoplasms
  • Ureteral Neoplasms
  • Urethral Neoplasms
  • Pelvic Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Bangor, Maine  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Belleville, New Jersey  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Allentown, Pennsylvania  
Research Site Pawtucket, Rhode Island  
Research Site Auburn, Washington  
Research Site Clarksburg, West Virginia