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A Dose Escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.
This study is not yet open for participant recruitment.
Verified by MedImmune LLC, December 2008
Sponsored by: MedImmune LLC
Information provided by: MedImmune LLC Identifier: NCT00816400

Evaluate the safety and tolerability of MEDI-575 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.

Condition Intervention Phase
Drug: MEDI-575
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title: A Phase 1, Multicenter, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, a Fully Human Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor Alpha (PDGFRα), in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of MEDI-575 and to determine the maximum tolerated dose in this subject population. [ Time Frame: 30 days after the last dose of MEDI-575. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess of PK, IM, and antitumor activity. [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: March 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
MEDI-575 (Dose escalation Cohort)
Drug: MEDI-575
Administered at a dose determined by the subject's enrollment cohort as a 60 min. IV infusion as part of a 21 day treatment cycle.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed advanced solid tumor for which no curative or standard therapies exist
  • Karnofsky performance status of ≥ 60
  • Adequate hematologic and organ function

Exclusion Criteria:

  • No prior treatment within 4 weeks of study drug administration
  • No concurrent therapy for treatment of cancer
  • No 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
  • Known brain metastases
  • Pregnancy or lactation or plans to become pregnant while on study
  • Clinically significant abnormality on ECG
  Contacts and Locations
Please refer to this study by its identifier: NCT00816400

Contact: Jill Schmidt 301-398-0000
Contact: Susan Sloan 301-398-0000

United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Indiana
Central Indiana Cancer Center
Indianapolis, Indiana, United States, 46219
United States, Nevada
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, Texas
Texas Oncology P.A.
Dallas, Texas, United States, 75246
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
MedImmune LLC
  More Information

Responsible Party: Medimmune LLC ( Robert Lechleider, MD )
Study ID Numbers: MI-CP187
Study First Received: December 23, 2008
Last Updated: December 30, 2008 Identifier: NCT00816400  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Immunoglobulins processed this record on January 13, 2009