AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours

May 13, 2011 updated by: AstraZeneca

A Phase I, Open-label, Dose-escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies

This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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
    • Osaka
      • Takatsuk, Osaka, Japan
        • Research Site
    • Shizuoka
      • Sunto-gun, Shizuoka, 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:

  • Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists
  • World Health Organisation (WHO) performance status 0 to 2
  • Life expectancy of at least 12 weeks

Exclusion Criteria:

  • Inadequate bone marrow reserve
  • Inadequate liver function, renal function or low hemoglobin
  • Unresolved toxicity from anti-cancer therapy

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: 1
AZD0530
Drug: AZD0530
oral, tablet, once daily, dose will be variable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of AEs, vital signs, ECG, laboratory findings, thoracic imaging and pulmonary function test.
Time Frame: Assessed on an ongoing basis after starting daily dosing with AZD0530
Assessed on an ongoing basis after starting daily dosing with AZD0530

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the single and multiple dose PK of AZD0530 when administered orally to patients with advanced solid malignancies by assessment of Cmin, Cmax, tmax, Cssmax, Cssmin, AUC0-t, AUC0-24, AUC, AUCss0-24, CL/F, t1/2 and R
Time Frame: 1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.
1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.
Tumor response
Time Frame: at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.
at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Chair: Mary Stuart, MD, AstraZeneca
  • Principal Investigator: Narikazu Boku, MD, Saint Marianna University School of Medicine

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

June 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 24, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8180C00021

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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