An Open-Label, Dose-Escalation Study of AZD2461
Completed · Phase 1
Conditions studied: Refractory Solid Tumors, Cancer Tumor
In brief
This study is being conducted to test study drug AZD2461 to see how it may work to treat solid tumors. The main purpose of this study is to determine the safety and tolerability of AZD2461. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD2461 in the body over a period of time and will indicate whether the drug has a therapeutic effect on solid tumors.
Key facts
- Study ID
- NCT01247168
- Run by
- AstraZeneca
- People needed
- 75
- Starts
- 2010-11-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2012-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with confirmed diagnosis of solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
- Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
- Patients must be 18 years of age
- Using adequate contraceptive measures, be surgically sterile or post-menopausal
- Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative testing. If tissue is not available, a patient will still be eligible for enrollment into the study..
You may not qualify if…
- Patients currently receiving cancer therapy
- Use of investigation anti-cancer drug or major surgery, radiotherapy or immunotherapy with the last 21 days
- cardiac disease
Where it is running
- Research Site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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