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

Condition(s): Cancer
NCTId: NCT00816400

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

Summary

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.

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years N/A False

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

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

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.

Study Outcomes

Primary Outcome(s)

Timeframe: 30 days after the last dose of MEDI-575.
Measure: Evaluate the safety and tolerability of MEDI-575 and to determine the maximum tolerated dose in this subject population.
Safety Issue? Yes

Secondary Outcome(s)

Measure: To assess of PK, IM, and antitumor activity.
Timeframe: 30 days after last dose of study drug
Safety Issue? Yes

Measure: To determine the maximum tolerated dose (MTD) and/or optimal biologic does of MEDI-575 in adult subjects with advanced solid tumors.
Timeframe: 30 days after last dose of study drug
Safety Issue? Yes

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations

Research Center
Norfolk, Virginia 23502 United States

Research Center
Dallas, Texas 75246 United States

Research Site
Las Vegas, Nevada 89169 United States

Research Center
Indianapolis, Indiana 46219 United States

Research Center
Denver, Colorado 80218 United States

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Cancer

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