A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients With Advanced Solid Malignancies
25 Years
N/A
Both
Cancer, Advanced Solid Malignancies
Trial Information
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients With Advanced Solid Malignancies
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability,
Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in
Japanese Patients with Advanced Solid Malignancies.
Inclusion Criteria:
- Japanese patients with advanced solid malignancies Over 25 years old Relatively good
overall health other than cancer
Exclusion Criteria:
- Poor bone marrow function (not producing enough blood cells). Poor liver or kidney
function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the IP or previous significant bowel resection.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination
Outcome Time Frame:
General examination prior to IP administration in treatment cycles
Safety Issue:
Yes
Principal Investigator
Paul Stockman
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D2610C00002
NCT ID:
NCT01213160
Start Date:
November 2011
Completion Date:
June 2013
Related Keywords:
- Cancer
- Advanced Solid Malignancies
- Phase I
- cancer
- solid tumours
- advanced solid malignancies
- dose escalation
- FGFR TKI
- Japanese
- Neoplasms
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