GMA16100104: Pharmacokinetics and Pharmacodynamic Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura

This study is currently recruiting patients.

Sponsored By:	Genzyme MacroGenics, Inc.
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00244257

Purpose

This study is designed to investigate the safety of a single infusion of GMA161 in patients with idiopathic thrombocytopenia purpura as well as the way the drug enters and leaves the body. In addition, throughout the study, platelet counts and other blood cell numbers will be measured.

Condition	Intervention	Phase
Idiopathic Thrombocytopenic Purpura	Drug: GMA161, Humanized Anti-Human CD16 Monoclonal Antibody	Phase I

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Safety Study

Official Title: Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamic Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura

Further Study Details
Primary Outcomes: Evaluate safety, tolerability and PK if single IV infusions of GMA161 in patients with ITP

Study Start: 2005-08; Study Completion: 2007-03

Last Follow-Up: 2007-02; Data Entry Closure: 2007-03

Eligibility Criteria

Ages Eligible for Study: 18 Years - N/A, Genders Eligible for Study: Both

Inclusion Criteria:

Willing and able to provide written informed consent prior to any study-related procedures

Chronic idiopathic thrombocytopenic purpura diagnosed for at least 6 months

A platelet count of < 100,000/mm^3 on 2 determinations at least 6 weeks apart, including 1 determination within 7 days prior to initiating study treatment. Patients on a stable dose of corticosteroids for 2 weeks prior to study entry and with a platelet count of < 100,000/mm^3 may be enrolled

Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1, with a life expectancy of at least 6 months

Exclusion Criteria:

Women who are pregnant or lactating

Women of childbearing potential unless using a medically acceptable contraceptive precaution with the use of spermicide or are sexually inactive

Women who plan to become pregnant within 6 months after the screening phase

Evidence of excessive bleeding requiring hospitalization within 6 weeks of study entry or a red cell transfusion within 6 weeks of study entry

Absolute neutrophil count < 2,000/mm^3

Total bilirubin > 2 mg/dL or alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times the upper limit of normal ranges in the institutional laboratory

Creatinine > 2 mg/dL

History of drug-induced thrombocytopenia, marrow failure syndrome, such as aplastic anemia or myelodysplasia, or thrombocytopenia related to viral or bacterial infection

Elevated (≥ 1.5 times the upper limit of normal range) prothrombin time (PT) or partial thromboplastin time (PTT) (other than related to a lupus anticoagulant or contact factor defect)

Evidence of active bacterial infection or viral infection

Active hemolysis that requires red cell transfusion within 6 weeks of study entry (Patients with evidence of concurrent autoimmune hemolysis [Evan’s Syndrome] will be allowed)

History of clinically significant cardiac or pulmonary disease

History of cancer, other than: basal cell skin cancer, squamous cell skin cancer with no previous chemotherapy treatment or disease-free carcinoma in situ of the cervix, for a minimum of 5 years from the time of Screening

HIV infection or acute or persistent hepatitis B and C viral infection (characterized by positive hepatitis B surface antigen (HBsAg), positive anti-hepatitis C virus [HCV] or polymerase chain reaction [PCR] assays for HCV)

History of concurrent autoimmune disorders requiring systemic treatment for involvement of organ systems other than cytopenias or thyroid disease

Treatment with cyclophosphamide, vincristine, rituximab, or any other monoclonal antibody within 12 weeks of study infusion

Treatment with intravenous immunoglobulin (IVIg) within 2 weeks of study drug infusion or Rh(D) immune globulin intravenous within 4 weeks of study drug infusion

Treatment with an agent, other than IVIg or corticosteroids, for ITP within 4 weeks of study entry. The dose level of corticosteroids may not be increased or decreased within 2 weeks of study entry

Use of any investigational drug within 12 weeks before Screening

Other pathology that might interfere with the assessment of the safety or efficacy of the test article or other clinically significant, uncontrolled medical condition that, in the Investigator’s opinion, might interfere with the assessment or follow-up.

Patients who have been splenectomized within 2 months of study entry.

Location Information

California
Scripps Cancer Center, San Diego, California, 92121, United States, Recruiting

Maryland
National Institutes of Health, Bethesda, Maryland, 20892, United States; Recruiting

Massachusetts
Brigham and Women’s Hospital, Boston, Massachusetts, 02115, United States, Recruiting

New York
Weill Medical College of Cornell University, New York, New York, 10021, United States; Recruiting

Ohio
The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Recruiting

More Information

Study ID Numbers: GMA16100104
ClinicalTrials.gov Identifier: NCT00244257
Health Authority: United States: Food and Drug Administration