AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours
A Phase I, Open-label, Dose-escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies
1 other identifier
interventional
18
1 country
2
Brief Summary
This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2008
Typical duration for phase_1
2 active sites
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
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 16, 2011
May 1, 2011
2.6 years
June 23, 2008
May 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of AEs, vital signs, ECG, laboratory findings, thoracic imaging and pulmonary function test.
Assessed on an ongoing basis after starting daily dosing with AZD0530
Secondary Outcomes (2)
To determine the single and multiple dose PK of AZD0530 when administered orally to patients with advanced solid malignancies by assessment of Cmin, Cmax, tmax, Cssmax, Cssmin, AUC0-t, AUC0-24, AUC, AUCss0-24, CL/F, t1/2 and R
1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.
Tumor response
at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.
Study Arms (1)
1
EXPERIMENTALAZD0530
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists
- World Health Organisation (WHO) performance status 0 to 2
- Life expectancy of at least 12 weeks
You may not qualify if:
- Inadequate bone marrow reserve
- Inadequate liver function, renal function or low hemoglobin
- Unresolved toxicity from anti-cancer therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Takatsuk, Osaka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Related Publications (1)
Fujisaka Y, Onozawa Y, Kurata T, Yasui H, Goto I, Yamazaki K, Machida N, Watanabe J, Shimada H, Shi X, Boku N. First report of the safety, tolerability, and pharmacokinetics of the Src kinase inhibitor saracatinib (AZD0530) in Japanese patients with advanced solid tumours. Invest New Drugs. 2013 Feb;31(1):108-14. doi: 10.1007/s10637-012-9809-7. Epub 2012 Mar 14.
PMID: 22415795DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Mary Stuart, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Narikazu Boku, MD
Saint Marianna University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 24, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2011
Study Completion
May 1, 2011
Last Updated
May 16, 2011
Record last verified: 2011-05