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

Phase 2

Completed

• Conditions: Bladder Cancer; Transitional Cell Bladder Cancer; Urethra Cancer; Ureter Cancer; Renal Pelvis Cancer
• Interventions: Drug: AZD4877

• Registration Number: NCT00661609
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Study Start: 2008-05
• Primary Completion: 2009-05
• Study Completion: 2009-12
• Results First Submitted: 2010-07-19
• Status Verified: 2010-12
• Results First Submitted QC: 2010-12-13
• Last Update Submitted: 2010-12-13
• Results First Posted: 2011-01-12
• Last Update Posted: 2011-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD4877	AZD4877	Single agent AZD4877

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)	8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)	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

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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Surrey, United Kingdom