Study Stopped
Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.
Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine
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
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 cancer
Started Jul 2009
Shorter than P25 for phase_1 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 9, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 7, 2011
February 1, 2011
1.6 years
July 9, 2009
February 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
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 Outcomes (2)
Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine
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)
Every 2-3 cycles
Study Arms (1)
AZD7762 + gemcitabine
OTHERAZD7762 administered alone and in combination with gemcitabine
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Poor bone marrow function (not producing enough blood cells).
- Poor liver or kidney function.
- Serious heart conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Minamiku, Fukuoka, Japan
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Langmuir, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Takashi Seto, MD, PhD
National Hospital Organization Kyushu Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 9, 2009
First Posted
July 13, 2009
Study Start
July 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 7, 2011
Record last verified: 2011-02