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

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00816400

Purpose

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
Cancer	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.

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
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 ClinicalTrials.gov identifier: NCT00816400

Contacts

Contact: Jill Schmidt	301-398-0000	SchmidtJ@medimmune.com
Contact: Susan Sloan	301-398-0000	SloanS@medimmune.com

Locations

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
ClinicalTrials.gov Identifier:	NCT00816400
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Immunoglobulins

ClinicalTrials.gov processed this record on January 13, 2009