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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-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, 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-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, 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 ≥60.

- Adequate hematological function.

- Adequate organ function.

- Women of non-child-bearing potential (defined as being >1 year post-menopausal) or
using effective contraception, e.g., use of oral contraceptives with an additional
barrier method (since the investigational product may impair the effectiveness of
oral contraceptives), double barrier methods (diaphragm with spermicidal gel or
condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total
abstinence, from the time the informed consent is signed through 30 days after the
last dose of MEDI-573. Male subjects with partners of child-bearing potential must be
surgically sterile or use contraceptive method as described above from the time of
the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.

Exclusion Criteria:

- No prior treatment within 4 weeks of study drug administration.

- No concurrent therapy for treatment of cancer.

- No uncontrolled 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.

- Documented brain metastasis.

- 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-573 and to determine the MTD and/or optimal biological dose of MEDI-573 in this subject population.

Outcome Time Frame:

30 days after patient's final dose of study drug

Safety Issue:

Yes

Principal Investigator

Susan Perez, MD, MSc

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

MI-CP184

NCT ID:

NCT00816361

Start Date:

March 2009

Completion Date:

October 2012

Related Keywords:

  • Cancer

Name

Location

Research SiteMesa, Arizona  
Research SiteBoca Raton, Florida  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteAllentown, Pennsylvania