Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01213160

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

13.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.

Condition or Disease	Intervention/Treatment	Phase
Cancer Advanced Solid Malignancies	Drug: AZD4547	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD4547	Drug: AZD4547 film coated tablet, PO, twice daily

Arm

Intervention/Treatment

Experimental: AZD4547

Drug: AZD4547

film coated tablet, PO, twice daily

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 150 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Chuo-ku	Japan
2	Research Site	Nagoya-shi	Japan
3	Research Site	Sapporo-shi	Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Paul Stockman, AstraZeneca
Principal Investigator: Hideo Saka, MD, PhD, National Hospital Organisation Nagoya Medical Centre
Principal Investigator: Yasuo Takahashi, MD, National Hospital OrganisationHokkaido Cancer Centre