Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

June 28, 2016 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chuo-ku, Japan
        • Research Site
      • Nagoya-shi, Japan
        • Research Site
      • Sapporo-shi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 150 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination
Time Frame: General examination prior to IP administration in treatment cycles
General examination prior to IP administration in treatment cycles
Assessment of adverse events (based on CTCAE version 4.0)general examination
Time Frame: General examination on day 1 in cycle 0
General examination on day 1 in cycle 0
Assessment of adverse events (based on CTCAE version 4.0)general examination
Time Frame: General examination day 21 in cycle 1.
General examination day 21 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Time Frame: Laboratory assessment prior to IP administration in all treatment cycles
Laboratory assessment prior to IP administration in all treatment cycles
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Time Frame: Laboratory assessment on day 1 in cycle 0
Laboratory assessment on day 1 in cycle 0
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Time Frame: Laboratory assessment day 1 cycle 1.
Laboratory assessment day 1 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Time Frame: Laboratory assessment day 8 cycle 1.
Laboratory assessment day 8 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Time Frame: Laboratory assessment day 15 cycle 1.
Laboratory assessment day 15 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Time Frame: Laboratory assessment day 21 cycle 1.
Laboratory assessment day 21 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Time Frame: Vital sign measurements prior to IP administration in all treatment cycles
Vital sign measurements prior to IP administration in all treatment cycles
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Time Frame: Vital sign measurements day 1 in cycle 0
Vital sign measurements day 1 in cycle 0
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Time Frame: Vital sign measurements day 2 in cycle 0
Vital sign measurements day 2 in cycle 0
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Time Frame: Vital sign measurements day 8 in cycle 1.
Vital sign measurements day 8 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Time Frame: Vital sign measurements day 21 in cycle 1.
Vital sign measurements day 21 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF)
Time Frame: LVEF prior to study administration
LVEF prior to study administration
Assessment of adverse events (based on CTCAE version 4.0), LVEF
Time Frame: LVEF on day 21 in cycle 1.
LVEF on day 21 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), eye examination
Time Frame: Eye examination prior to study administration
Eye examination prior to study administration
Assessment of adverse events (based on CTCAE version 4.0), eye examination
Time Frame: Eye examination on day 21 in cycle 1.
Eye examination on day 21 in cycle 1.

Secondary Outcome Measures

Outcome Measure
Time Frame
Define the maximum tolerated dose (MTD) if possible or biological effective dose.
Time Frame: Up to 3 weeks
Up to 3 weeks
To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally.
Time Frame: 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
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.
Time Frame: Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment
Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 1, 2010

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2610C00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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