AZD5438 in Patients With Advanced Solid Malignancies

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00088790

First received: August 4, 2004

Last updated: January 25, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 4, 2004
Last Updated Date	January 25, 2011
Start Date ^ICMJE	July 2004
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00088790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	AZD5438 in Patients With Advanced Solid Malignancies
Official Title ^ICMJE	Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies
Brief Summary	Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Neoplasms
Intervention ^ICMJE	Drug: AZD5438
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	December 2005
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Advanced solid malignancy Cancer refractory to standard treatments or for which no standard therapy exits Exclusion Criteria: Radiotherapy within 3 weeks of the start of treatment Investigational product within the last 3 weeks Systemic cytotoxic anti-cancer therapy within the last 3 weeks Any significant clinical disorder that makes it undesirable for the patient to participate
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00088790
Other Study ID Numbers ^ICMJE	D0110C00005
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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