Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan

February 10, 2011 updated by: AstraZeneca

A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.

This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The study is sponsored by AstraZeneca.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • 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:

  • Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
  • Must be suitable for treatment with irinotecan
  • Relatively good overall health other than your cancer

Exclusion Criteria:

  • Poor bone marrow function (not producing enough blood cells)
  • Serious heart conditions
  • Poor liver or kidney function
  • Any prior anthracycline treatment

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD7762 monotherapy followed by AZD7762 + irinotecan
Drug: AZD7762
intravenous infusion
Drug: Irinotecan
intravenous injection
Other Names:
  • Camptosar®
  • irinotecan hydrochloride
  • Campto®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan
Time Frame: assessed after each course of treatment
assessed after each course of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.
Time Frame: assessed after each course of treatment
assessed after each course of treatment

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Peter Langmuir, MD, AstraZeneca

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

May 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 15, 2007

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1040C00004

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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