Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055

June 14, 2011 updated by: AstraZeneca

A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours

The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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
      • Tokyo, 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective
  • Relatively good overall health other than cancer

Exclusion Criteria:

  • Poor bone marrow function (not producing enough blood cells)
  • Poor liver or kidney function
  • Serious concomitant illness

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD8055
AZD8055 will be administered orally
Drug: AZD8055
Tablets, orally administered, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
Time Frame: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours
Time Frame: According to protocol specified schedule, the number of PK samples collected during Cycle 1
According to protocol specified schedule, the number of PK samples collected during Cycle 1
To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)
Time Frame: Every cycle
Every cycle

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Ian Smith, AstraZeneca
  • Principal Investigator: Tomohide Tamura, National Cancer Center Hospital

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

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

August 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 7, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1600C00003

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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