Cancer, Advanced Solid Malignancies
Conditions
Keywords
Phase I, cancer, solid tumours, advanced solid malignancies, dose escalation, FGFR TKI, Japanese
Brief summary
The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.
Detailed description
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.
Interventions
DRUGAZD4547
film coated tablet, PO, twice daily
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 150 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of adverse events (based on CTCAE version 4.0), eye examination | Eye examination prior to study administration |
| Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements | Vital sign measurements prior to IP administration in all treatment cycles |
| Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF) | LVEF prior to study administration |
| Assessment of adverse events (based on CTCAE version 4.0), LVEF | LVEF on day 21 in cycle 1. |
| Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination | General examination prior to IP administration in treatment cycles |
| Assessment of adverse events (based on CTCAE version 4.0)general examination | General examination on day 1 in cycle 0 |
| Assessment of adverse events (based on CTCAE version 4.0), laboratory values | Laboratory assessment prior to IP administration in all treatment cycles |
Secondary
| Measure | Time frame |
|---|---|
| To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally. | Schedule of PK assessment 1. AZD4547; blood Cycle0-day1 -day21; 27 point 2. AZD4547 metabolite; blood Cycle1-day21; 1 poin 3. AZD4547; urine Cycle1-day21; 1 point |
| To obtain a preliminary assessment of the anti-tumour effect of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. | Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment |
| Define the maximum tolerated dose (MTD) if possible or biological effective dose. | Up to 3 weeks |
Countries
Japan
Outcome results
None listed