Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055
A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours
1 other identifier
interventional
19
1 country
1
Brief Summary
The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.
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 Aug 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 7, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 15, 2011
June 1, 2011
1.3 years
September 7, 2009
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
Secondary Outcomes (2)
To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours
According to protocol specified schedule, the number of PK samples collected during Cycle 1
To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)
Every cycle
Study Arms (1)
AZD8055
EXPERIMENTALAZD8055 will be administered orally
Interventions
Eligibility Criteria
You may qualify if:
- Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective
- 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 concomitant illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Tokyo, Japan
Related Publications (1)
Asahina H, Nokihara H, Yamamoto N, Yamada Y, Tamura Y, Honda K, Seki Y, Tanabe Y, Shimada H, Shi X, Tamura T. Safety and tolerability of AZD8055 in Japanese patients with advanced solid tumors; a dose-finding phase I study. Invest New Drugs. 2013 Jun;31(3):677-84. doi: 10.1007/s10637-012-9860-4. Epub 2012 Jul 28.
PMID: 22843211DERIVED
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Ian Smith
AstraZeneca
- PRINCIPAL INVESTIGATOR
Tomohide Tamura
National Cancer Center Hospital
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
September 7, 2009
First Posted
September 9, 2009
Study Start
August 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 15, 2011
Record last verified: 2011-06