- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00473616
Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan
February 10, 2011 updated by: AstraZeneca
A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.
This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan.
The study is sponsored by AstraZeneca.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
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
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Research Site
-
-
New York
-
New York, New York, United States
- Research Site
-
-
Tennessee
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Nashville, Tennessee, United States
- Research Site
-
-
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 tumors for which standard treatment doesn't exist or is no longer effective.
- Must be suitable for treatment with irinotecan
- Relatively good overall health other than your cancer
Exclusion Criteria:
- Poor bone marrow function (not producing enough blood cells)
- Serious heart conditions
- Poor liver or kidney function
- Any prior anthracycline treatment
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
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
AZD7762 monotherapy followed by AZD7762 + irinotecan
|
intravenous infusion
intravenous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan
Time Frame: assessed after each course of treatment
|
assessed after each course of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.
Time Frame: assessed after each course of treatment
|
assessed after each course of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Peter Langmuir, MD, AstraZeneca
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
May 1, 2007
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
May 14, 2007
First Submitted That Met QC Criteria
May 14, 2007
First Posted (Estimate)
May 15, 2007
Study Record Updates
Last Update Posted (Estimate)
February 11, 2011
Last Update Submitted That Met QC Criteria
February 10, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1040C00004
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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