Status:
COMPLETED
A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.
Lead Sponsor:
MedImmune LLC
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00816400
Start Date
March 2 2009
End Date
January 19 2012
Last Update
June 26 2018
Active Locations (5)
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1
Research Site
Denver, Colorado, United States
2
Research Site
Indianapolis, Indiana, United States
3
Research Site
Las Vegas, Nevada, United States
4
Research Site
Dallas, Texas, United States