Phase I Study in Patients With Solid Tumours

September 21, 2010 updated by: AstraZeneca

A Phase I, Open-label Study to Assess the Safety and Tolerability of AZD0530 in Combination With Carboplatin and/or Paclitaxel Chemotherapy in Patients With Solid Tumours

This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2 phases are part of a single study and described by this single protocol. Patients entered into the dose escalation phase will not be entered into the expansion phase. All subjects must be suitable for treatment with either carboplatin and/or paclitaxel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

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

  • France
      • Paris, France
        • Research Site
      • Pierre Benite Cedex, France
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
  • Norway
      • Oslo, Norway
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Research Site
      • Sutton, United Kingdom
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Life expectancy > 12 weeks
  • Women defined as post-menopausal
  • Male or female patients with locally advanced or metastatic cancer suitable for treatment with carboplatin and/or paclitaxel

Exclusion Criteria:

  • Inadequate bone marrow reserve
  • Inadequate live function, renal function or low haemoglobin
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD0530 + Paclitaxel
Drug: Paclitaxel
intravenous infusion
Drug: AZD0530
oral tablet
Experimental: 2
AZD0530 + Carboplatin
Drug: AZD0530
oral tablet
Drug: Carboplatin
intravenous infusion
Experimental: 3
AZD0530 + Carboplatin + Paclitaxel
Drug: Paclitaxel
intravenous infusion
Drug: AZD0530
oral tablet
Drug: Carboplatin
intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.
Time Frame: Assessed at each visit
Assessed at each visit

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the Maximum Tolerated Dose of AZD0530 when administered in combination with carboplatin and/or paclitaxel by assessment of safety and tolerability data generated for each treatment arm.
Time Frame: Assessed at each visit
Assessed at each visit
To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers.
Time Frame: Assessment at end of study
Assessment at end of study
To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters.
Time Frame: Predetermined timepoints after dose administration
Predetermined timepoints after dose administration

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Mary Stuart, MD, AstraZeneca
  • Principal Investigator: Steinar Aamdal, MD, Radium Hospital, Norway

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

March 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (Estimate)

July 4, 2007

Study Record Updates

Last Update Posted (Estimate)

September 22, 2010

Last Update Submitted That Met QC Criteria

September 21, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8180C00023
  • AZD0530 study 23

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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