Status:
COMPLETED
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
Lead Sponsor:
MedImmune LLC
Conditions:
Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
Evaluate the safety and tolerability of MEDI-573 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 ≥60.
- Adequate hematological function.
- Adequate organ function.
- Women of non-child-bearing potential (defined as being \>1 year post-menopausal) or using effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the investigational product may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of MEDI-573. Male subjects with partners of child-bearing potential must be surgically sterile or use contraceptive method as described above from the time of the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.
Exclusion
- No prior treatment within 4 weeks of study drug administration.
- No concurrent therapy for treatment of cancer.
- No uncontrolled 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.
- Documented brain metastasis.
- Pregnancy or lactation or plans to become pregnant while on study.
- Clinically significant abnormality on ECG.
Key Trial Info
Start Date :
March 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00816361
Start Date
March 9 2009
End Date
September 11 2012
Last Update
March 4 2019
Active Locations (6)
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1
Research Site
Scottsdale, Arizona, United States, 85259
2
Research Site
Jacksonville, Florida, United States, 32224
3
Research Site
Boston, Massachusetts, United States, 02115
4
Research Site
Detroit, Michigan, United States, 48201