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

This study has been completed.

Study NCT00661609 Information provided by AstraZeneca

First Received on April 16, 2008. Last Updated on December 13, 2010 History of Changes

Results First Received: July 19, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Bladder Cancer Transitional Cell Bladder Cancer Urethra Cancer Ureter Cancer Renal Pelvis Cancer
Intervention:	Drug: AZD4877

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 23 study sites in 5 countries: United States (7 centers), United Kingdom (6 centers), Germany (5 centers), Canada (3 centers), and Spain (2 centers) between 29 May 2008 and 11 January 2010. 54 participants were enrolled into the study of which 41 participants received at least one dose of study medication.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following enrolment there was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with AZD4877.

Reporting Groups

	Description
AZD4877	AZD4877 25 mg (Intravenous (IV), 25mg weekly)

Participant Flow: Overall Study

	AZD4877
STARTED	41 ^[1]
COMPLETED	0 ^[2]
NOT COMPLETED	41
Adverse Event	4
Death	20
Withdrawal by Subject	2
PI Decision	1
Survival follow up stage discontinued	11
Disease progression	3

[1]	All dosed patients
[2]	Treatment is not for a fixed period and continues until a discontinuation criterion is met.

Baseline Characteristics

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Reporting Groups

	Description
AZD4877	AZD4877 25 mg (Intravenous (IV), 25mg weekly)

Baseline Measures

	AZD4877
Number of Participants [units: participants]	41
Age, Customized [units: Participants]
>=18 - <65 Years	17
>=65 - <75 Years	19
>=75 Years	5
Gender [units: Participants]
Female	11
Male	30
Race/Ethnicity, Customized [units: participants]
White	40
Black and African	1

Outcome Measures

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1. Primary:

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) ]

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2. Secondary:

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) ]

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3. Secondary:

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) ]

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4. Secondary:

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) ]

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5. Secondary:

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) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites. AZ has the right to request delays: up to 60 days for confidential information, and an additional 90 days to protect intellectual property.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

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