Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

December 9, 2010 updated by: AstraZeneca

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

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
    • Colorado
      • Aurora, Colorado, 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 does not exist or is no longer effective.
  • For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed.
  • 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
  • History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: gemcitabine
gemcitabine administered in combination with AZD6918
Drug: gemcitabine
intravenous, doses are on an intermittent schedule
Other Names:
  • Gemzar
EXPERIMENTAL: pemetrexed
pemetrexed administered in combination with AZD6918
Drug: pemetrexed
intravenous, dose administered every 21-days
Other Names:
  • Alimta
EXPERIMENTAL: AZD6918
AZD6918 administered alone
Drug: AZD6918
liquid suspension, daily, oral dose

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, Karnofsky performance status
Time Frame: Weekly for first two treatment cycles, then every 2-4 weeks
Weekly for first two treatment cycles, then every 2-4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy
Time Frame: According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy
According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Lia Gore, MD, University of Colorado, Denver

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, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (ESTIMATE)

August 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2785C00002

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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