A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.

Completed · Phase 1

Conditions studied: Cancer

In brief

Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.

Key facts

Study ID

NCT00816400

Run by

MedImmune LLC

People needed

49

Starts

2009-03-02

Expected to finish

2012-01-19

Last updated by the study team

2018-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed advanced solid tumor for which no curative or standard therapies exist
• Karnofsky performance status of ≥ 60
• Life expectancy of >12 weeks
• Adequate hematologic and organ function
• Negative serum pregnancy test (women only)
• Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential

You may not qualify if…

• Prior chemotherapy or investigational treatment within 4 weeks of study drug administration
• Prior biological or immunological treatment within 6 weeks of study drug administration
• Concurrent therapy for of cancer
• Major surgery within four weeks or minor surgery within two weeks of study drug administration
• History of diabetes or current treatment for diabetes
• New York Heart Association ≥ Grade 2 congestive heart failure
• History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry
• History of other invasive malignancy within 5 years (exceptions are cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that are surgically cured)
• Significant active infection
• Known brain metastases
• Pregnancy or lactation or plans to become pregnant while on study
• Clinically significant abnormality on ECG

Where it is running

• Research Site — Denver, Colorado, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Dallas, Texas, United States
• Research Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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