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Active Not RecruitingNCT00600496

A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)

A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
140 (actual)
Sponsor
AstraZeneca · Industry
Sex
All
Age
18 Years – 130 Years
Healthy volunteers
Not accepted

Summary

This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies

Conditions

Interventions

TypeNameDescription
DRUGAZD6244twice daily oral dose
DRUGDacarbazineintravenous infusion
DRUGErlotinibdaily oral dose
DRUGDocetaxelintravenous infusion
DRUGTemsirolimusintravenous infusion

Timeline

Start date
2007-12-14
Primary completion
2010-08-20
Completion
2025-12-31
First posted
2008-01-25
Last updated
2025-11-13

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00600496. Inclusion in this directory is not an endorsement.

A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-14288 (NCT00600496) · Clinical Trials Directory