Completed

Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitlePhase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies 
NCT00088790
Principal SponsorAstraZeneca
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neoplasms
Criteria

Inclusion Criteria: * Advanced solid malignancy * Cancer refractory to standard treatments or for which no standard therapy exits Exclusion Criteria: * 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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Research SiteBoston, United StatesSee the location
Suspended
Research SiteNew York City, United States
Completed2 Study Centers