- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00704366
AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours
May 13, 2011 updated by: AstraZeneca
A Phase I, Open-label, Dose-escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies
This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
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
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Osaka
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Takatsuk, Osaka, Japan
- Research Site
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Shizuoka
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Sunto-gun, Shizuoka, Japan
- Research Site
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inadequate bone marrow reserve
- Inadequate liver function, renal function or low hemoglobin
- Unresolved toxicity from anti-cancer therapy
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
AZD0530
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oral, tablet, once daily, dose will be variable
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: Assessed on an ongoing basis after starting daily dosing with AZD0530
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Assessed on an ongoing basis after starting daily dosing with AZD0530
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 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.
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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
Time Frame: at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.
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at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mary Stuart, MD, AstraZeneca
- Principal Investigator: Narikazu Boku, MD, Saint Marianna University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
June 1, 2008
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
June 23, 2008
First Submitted That Met QC Criteria
June 23, 2008
First Posted (Estimate)
June 24, 2008
Study Record Updates
Last Update Posted (Estimate)
May 16, 2011
Last Update Submitted That Met QC Criteria
May 13, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D8180C00021
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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Aadi Bioscience, Inc.RecruitingAdvanced Solid Tumor | Tumor | Tumor, SolidUnited States
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RemeGen Co., Ltd.CompletedMetastatic Solid Tumor | Locally Advanced Solid Tumor | Unresectable Solid TumorAustralia
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-
BeiGeneRecruitingSolid Tumor | Advanced Solid TumorUnited States, New Zealand, Australia, China
Clinical Trials on AZD0530
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-
National Cancer Institute (NCI)TerminatedInvasive Thymoma and Thymic Carcinoma | Recurrent Thymoma and Thymic Carcinoma | Stage III Thymoma | Stage IVA Thymoma | Stage IVB ThymomaUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Stage III Gastric Cancer | Adenocarcinoma of the Stomach | Stage IV Esophageal Cancer | Stage III Esophageal CancerCanada, United States
-
National Cancer Institute (NCI)CompletedLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Malignant Pleural EffusionUnited States