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
20 Years
N/A
Both
Cancer, Solid Tumors, Advanced Solid Malignancies
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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)
Outcome Time Frame:
Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
Safety Issue:
Yes
Principal Investigator
Ian Smith
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D1600C00003
NCT ID:
NCT00973076
Start Date:
August 2009
Completion Date:
December 2010
Related Keywords:
- Cancer
- Solid Tumors
- Advanced Solid Malignancies
- Phase I, cancer
- solid tumors
- advanced solid malignancies
- dose escalation
- mTOR Kinase Inhibitor
- Japanese
- Neoplasms
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