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

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) [ 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) ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

Disease Control Rate (DCR) [ Time Frame: 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks) ] [ Designated as safety issue: No ]
Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).
Duration of Objective Tumor Response (OTR) [ Time Frame: 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) ] [ Designated as safety issue: No ]
Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)
Progression Free Survival (PFS) [ Time Frame: Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) ] [ Designated as safety issue: No ]
Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.
Overall Survival (OS) [ Time Frame: Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks) ] [ Designated as safety issue: No ]
Time in weeks from the first administration of study drug to death.

Enrollment:	54
Study Start Date:	May 2008
Study Completion Date:	December 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD4877 Single agent AZD4877	Drug: AZD4877 Intravenous (IV)25mg/weekly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661609

Show 36 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Gary Hudes, MD

Fox Chase Cancer Center

More Information

Additional Information:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jeffrey Skolnik, MD/Associate Medical Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00661609 History of Changes
Other Study ID Numbers:	D2782C00010
Study First Received:	April 16, 2008
Results First Received:	July 19, 2010
Last Updated:	December 13, 2010
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

Keywords provided by AstraZeneca:

Anti-mitotic
Eg5 Inhibitor
Kinesin Spindle Protein Inhibitor
Urothelial Cancer
Bladder Cancer
Renal Pelvis Cancer

Urethra Cancer
Ureter Cancer
Recurrent
Advanced
Stage IV

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Urethral Neoplasms
Pelvic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases

Urologic Diseases
Kidney Diseases
Ureteral Diseases
Urethral Diseases
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012