Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Cancer, Advanced Solid Malignancies

Intervention / Treatment
-----------------
* Drug: AZD4547


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 150 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD4547<br> | Drug: AZD4547<br>* film coated tablet, PO, twice daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)general examination |  | General examination day 21 in cycle 1. | 
| Assessment of adverse events (based on CTCAE version 4.0), laboratory values |  | Laboratory assessment prior to IP administration in all treatment cycles | 
| Assessment of adverse events (based on CTCAE version 4.0), laboratory values |  | Laboratory assessment on day 1 in cycle 0 | 
| Assessment of adverse events (based on CTCAE version 4.0), laboratory values |  | Laboratory assessment day 1 cycle 1. | 
| Assessment of adverse events (based on CTCAE version 4.0), laboratory values |  | Laboratory assessment day 8 cycle 1. | 
| Assessment of adverse events (based on CTCAE version 4.0), laboratory values |  | Laboratory assessment day 15 cycle 1. | 
| Assessment of adverse events (based on CTCAE version 4.0), laboratory values |  | Laboratory assessment day 21 cycle 1. | 
| 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), vital sign measurements |  | Vital sign measurements day 1 in cycle 0 | 
| Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements |  | Vital sign measurements day 2 in cycle 0 | 
| Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements |  | Vital sign measurements day 8 in cycle 1. | 
| Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements |  | Vital sign measurements day 21 in cycle 1. | 
| 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 CTCAE version 4.0), eye examination |  | Eye examination prior to study administration | 
| Assessment of adverse events (based on CTCAE version 4.0), eye examination |  | Eye examination on day 21 in cycle 1. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define the maximum tolerated dose (MTD) if possible or biological effective dose. |  | Up to 3 weeks | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, cancer, solid tumours, advanced solid malignancies, dose escalation, FGFR TKI, Japanese