AZD5438 in Patients With Advanced Solid Malignancies

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088790
• Other study ID #: D0110C00005
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2004
• Last updated: January 25, 2011
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• AZD5438

Locations

Country	Name	City	State
United States	Research Site	Boston	Massachusetts
United States	Research Site	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States,