- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00088790
AZD5438 in Patients With Advanced Solid Malignancies
January 25, 2011 updated by: AstraZeneca
Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies
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.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States
- Research Site
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New York
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New York City, New York, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
August 4, 2004
First Submitted That Met QC Criteria
August 4, 2004
First Posted (Estimate)
August 5, 2004
Study Record Updates
Last Update Posted (Estimate)
January 26, 2011
Last Update Submitted That Met QC Criteria
January 25, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D0110C00005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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