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

This study is ongoing, but not recruiting participants.

First Received on December 23, 2008. Last Updated on January 17, 2012 History of Changes

Sponsor:	MedImmune LLC
Information provided by (Responsible Party):	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00816400

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 I

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:	March 2009
Estimated Study Completion Date:	March 2012
Estimated 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

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 Center
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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

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:	January 17, 2012
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 09, 2012