A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer

NCT00661609 | Completed Phase 2 Results

• 1 other identifier: D2782C00010
• Study Type: interventional
• Target: 54
• Locations: 5 countries
• Sites: 36

Brief Summary

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

Conditions

Bladder Cancer; Transitional Cell Bladder Cancer; Urethra Cancer; Ureter Cancer; Renal Pelvis Cancer

Keywords

Anti-mitotic; Eg5 Inhibitor; Kinesin Spindle Protein Inhibitor; Urothelial Cancer; Bladder Cancer; Renal Pelvis Cancer; Urethra Cancer; Ureter Cancer; Recurrent; Advanced; Stage IV

Outcome Measures

Primary Outcomes (1)

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

  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).

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

Secondary Outcomes (4)

• Disease Control Rate (DCR)

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

• Duration of Objective Tumor Response (OTR)

  Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)

• Progression Free Survival (PFS)

  Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)

• Overall Survival (OS)

  Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)

Study Arms (1)

AZD4877

EXPERIMENTAL

Single agent AZD4877

Drug: AZD4877

Interventions

AZD4877 DRUG

Intravenous (IV)25mg/weekly

AZD4877

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (36)

Research Site

Palo Alto, California, United States

Location

Research Site

San Bernardino, California, United States

Location

Research Site

Southington, Connecticut, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Atlanta, Georgia, United States

Location

Research Site

Marietta, Georgia, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Scarborough, Maine, United States

Location

Research Site

Ann Arbor, Michigan, United States

Location

Research Site

Minneapolis, Minnesota, United States

Location

Research Site

Hackensack, New Jersey, United States

Location

Research Site

Morristown, New Jersey, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Charlotte, North Carolina, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Woonsocket, Rhode Island, United States

Location

Research Site

Seattle, Washington, United States

Location

Research Site

Morgantown, West Virginia, United States

Location

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

Halifax, Nova Scotia, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Berlin, Germany

Location

Research Site

Dresden, Germany

Location

Research Site

Düsseldorf, Germany

Location

Research Site

München, Germany

Location

Research Site

Münster, Germany

Location

Research Site

Barcelona, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Leeds, West Yorkshire, United Kingdom

Location

Research Site

Glasgow, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Research Site

Southampton, United Kingdom

Location

Research Site

Surrey, United Kingdom

Location

Related Publications (1)

• Jones R, Vuky J, Elliott T, Mead G, Arranz JA, Chester J, Chowdhury S, Dudek AZ, Muller-Mattheis V, Grimm MO, Gschwend JE, Wulfing C, Albers P, Li J, Osmukhina A, Skolnik J, Hudes G. Phase II study to assess the efficacy, safety and tolerability of the mitotic spindle kinesin inhibitor AZD4877 in patients with recurrent advanced urothelial cancer. Invest New Drugs. 2013 Aug;31(4):1001-7. doi: 10.1007/s10637-013-9926-y. Epub 2013 Jan 18.

  PMID: 23329066 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms; Ureteral Neoplasms; Recurrence

Interventions

N-(3-aminopropyl)-N-(1-(5-benzyl-3-methyl-4-oxo-(1,2)thiazolo(5,4-d)pyrimidin-6-yl)-2-methylpropyl)-4-methylbenzamide

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases; Ureteral Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Gary Hudes, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 12, 2011
• Results First Posted: January 12, 2011

Record last verified: 2010-12

Locations

GB (6); ES (2); CA (5); US (18); DE (5)