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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00816361
First received: December 23, 2008
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Cancer
Drug: MEDI-573
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Enrollment: 43
Study Start Date: March 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816361

Locations
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
Investigators
Study Director: Susan Perez, MD, MSc MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00816361     History of Changes
Other Study ID Numbers: MI-CP184
Study First Received: December 23, 2008
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 20, 2014