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

Launched by MEDIMMUNE LLC · Dec 30, 2008

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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