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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


Phase 1
20 Years
N/A
Not Enrolling
Both
Advanced Solid Malignancies

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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

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