- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00937664
Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine
February 4, 2011 updated by: AstraZeneca
A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
Fukuoka
-
Minami-ku, Fukuoka, Japan
- 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
20 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.
- Must be suitable for treatment with gemcitabine
- Relatively good overall health other than cancer
Exclusion Criteria:
- Poor bone marrow function (not producing enough blood cells).
- Poor liver or kidney function.
- Serious heart conditions
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: AZD7762 + gemcitabine
AZD7762 administered alone and in combination with gemcitabine
|
solution, intravenous, weekly
intravenous, weekly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
Time Frame: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2
|
Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine
Time Frame: According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1
|
According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1
|
Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Every 2-3 cycles
|
Every 2-3 cycles
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Peter Langmuir, MD, AstraZeneca
- Principal Investigator: Takashi Seto, MD, PhD, National Hospital Organization Kyushu Cancer Center
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, 2009
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
February 1, 2011
Study Registration Dates
First Submitted
July 9, 2009
First Submitted That Met QC Criteria
July 10, 2009
First Posted (Estimate)
July 13, 2009
Study Record Updates
Last Update Posted (Estimate)
February 7, 2011
Last Update Submitted That Met QC Criteria
February 4, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1040C00008
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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