NCT00088790

Brief Summary

Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

1.4 years

First QC Date

August 4, 2004

Last Update Submit

January 25, 2011

Conditions

Neoplasms

Keywords

advanced, solid, malignancies

Interventions

AZD5438DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced solid malignancy
  • Cancer refractory to standard treatments or for which no standard therapy exits

You may not qualify if:

  • Radiotherapy within 3 weeks of the start of treatment
  • Investigational product within the last 3 weeks
  • Systemic cytotoxic anti-cancer therapy within the last 3 weeks
  • Any significant clinical disorder that makes it undesirable for the patient to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Boston, Massachusetts, United States

Location

Research Site

New York, New York, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

AZD5438

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

July 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

January 26, 2011

Record last verified: 2011-01

Locations

US(2)