Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

February 4, 2011 updated by: AstraZeneca

A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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
    • Fukuoka
      • Minami-ku, Fukuoka, 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 to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Poor bone marrow function (not producing enough blood cells).
  • Poor liver or kidney function.
  • Serious heart conditions

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
Other: AZD7762 + gemcitabine
AZD7762 administered alone and in combination with gemcitabine
Drug: AZD7762
solution, intravenous, weekly
Drug: gemcitabine
intravenous, weekly
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
Time Frame: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2
Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine
Time Frame: According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1
According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1
Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Every 2-3 cycles
Every 2-3 cycles

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
  • Principal Investigator: Takashi Seto, MD, PhD, National Hospital Organization Kyushu Cancer Center

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

July 1, 2009

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimate)

July 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 7, 2011

Last Update Submitted That Met QC Criteria

February 4, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1040C00008

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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