Trial Information
A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies
Inclusion Criteria:
- Having advanced solid malignancy for which no curative or standard therapies exist
- Karnofsky performance status of ≥60
- Patients must have histological confirmed diagnosis of HCC with no standard therapy
available (for only expansion part)
Exclusion Criteria:
- Inadequate bone marrow reserve or organ function
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of
MEDI-575. Patients must have no unhealed wounds or unhealed fractures
- History of allergy or reaction to any component of the MEDI-575 and/or monoclonal
antibody
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign
Outcome Time Frame:
30 days after the last dose of MEDI-575
Safety Issue:
Yes
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D2840C00001
NCT ID:
NCT01102400
Start Date:
March 2010
Completion Date:
November 2012
Related Keywords:
- Advanced Solid Malignancies
- cancer
- tumor
- hepatocellular carcinoma
- Neoplasms