A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00816400
First received: December 23, 2008
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Cancer
Drug: MEDI-575
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-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

Resource links provided by NLM:


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 ]
  • To determine the maximum tolerated dose (MTD) and/or optimal biologic does of MEDI-575 in adult subjects with advanced solid tumors. [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: January 2009
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-575 (Dose escalation and Dose Expansion Cohort)
Drug: MEDI-575
Administered at a dose determined by the subjects enrollment cohort as a 60 or 90 min. 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 of ≥ 60
  • Life expectancy of >12 weeks
  • Adequate hematologic and organ function
  • Negative serum pregnancy test (women only)
  • Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential

Exclusion Criteria:

  • Prior chemotherapy or investigational treatment within 4 weeks of study drug administration
  • Prior biological or immunological treatment within 6 weeks of study drug administration
  • Concurrent therapy for of cancer
  • Major surgery within four weeks or minor surgery within two weeks of study drug administration
  • 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
  • History of other invasive malignancy within 5 years (exceptions are cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that are surgically cured)
  • Significant active infection
  • Known brain metastases
  • 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: NCT00816400

Locations
United States, Colorado
Research Center
Denver, Colorado, United States, 80218
United States, Indiana
Research Center
Indianapolis, Indiana, United States, 46219
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89169
United States, Texas
Research Center
Dallas, Texas, United States, 75246
United States, Virginia
Research Center
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Robert Sikorski, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00816400     History of Changes
Other Study ID Numbers: MI-CP187
Study First Received: December 23, 2008
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014