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A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00816361
Recruitment Status : Completed
First Posted : January 1, 2009
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: MEDI-573 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists
Study Start Date : March 2009
Primary Completion Date : September 2012
Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
MEDI-573 - (Dose escalation Cohort)
Drug: MEDI-573
Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle.

Outcome Measures

Primary Outcome Measures :
  1. Evaluate the safety and tolerability of MEDI-573 and to determine the MTD and/or optimal biological dose of MEDI-573 in this subject population. [ Time Frame: 30 days after patient's final dose of study drug ]

Secondary Outcome Measures :
  1. Include assessments of PK, IM, pharmacodynamic, and antitumor activity of MEDI-573. [ Time Frame: 30 days after last dose of study drug/per subject ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816361

United States, Arizona
Research Site
Scottsdale, Arizona, United States, 32224
United States, Florida
Research Site
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
MedImmune LLC
Study Director: Susan Perez, MD, MSc MedImmune LLC
More Information

Additional Information:
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00816361     History of Changes
Other Study ID Numbers: MI-CP184
First Posted: January 1, 2009    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014