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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety and tolerability of MEDI-575 and to determine the maximum tolerated dose in this subject population.

Outcome Time Frame:

30 days after the last dose of MEDI-575.

Safety Issue:

Yes

Principal Investigator

Robert Sikorski, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

MI-CP187

NCT ID:

NCT00816400

Start Date:

January 2009

Completion Date:

April 2012

Related Keywords:

  • Cancer

Name

Location

Research SiteLas Vegas, Nevada  
Research CenterArlington, Texas  76012
Research CenterDenver, Colorado  80218
Research CenterIndianapolis, Indiana  46219
Research CenterNorfolk, Virginia  23502