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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00973076
Other study ID # D1600C00003
Secondary ID
Status Completed
Phase Phase 1
First received September 7, 2009
Last updated June 14, 2011
Start date August 2009
Est. completion date December 2010

Study information

Verified date June 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Poor bone marrow function (not producing enough blood cells)

- Poor liver or kidney function

- Serious concomitant illness

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AZD8055
Tablets, orally administered, twice daily

Locations

Country Name City State
Japan Research Site Tokyo

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Yes
Secondary 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 No
Secondary 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 No
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