NCT00428766CompletedPhase 1
A Study of the Safety, Tolerability, and Pharamcokinetics of MORAb-003, a Humanized Monoclonal Antibody, in Subjects With Advanced Ovarian Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Morphotek
- Enrollment
- 24
- Locations
- 1
Study Overview
Brief Summary
The purpose of this study is to establish the safest dose of MORAb-003 in subjects with advanced ovarian cancer. MORAb-003 is an antibody directed to an antigen on the surface of ovarian cancer cells.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female subjects, ≥18 years of age, with a histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal adenocarcinoma, with or without elevation of CA 125, confirmed at the Department of Pathology, Memorial Sloan-Kettering Cancer Center.
- •Subject must have disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by CA-125, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
- •Subject must have failed at least a standard (platinum-containing) chemotherapy regimen and be considered platinum refractory or resistant.
- •Life expectancy ≥3 months, as estimated by the investigator.
- •Karnofsky performance status ≥70%.
- •Subjects must be surgically sterile, postmenopausal, or using an effective form of contraception.
- •Subjects undergoing treatment with other medications must have been on a stable medication regimen for at least 30 days prior to Study Day
- •Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
- •Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥100 x 109/L Hemoglobin ≥10 g/dL Serum bilirubin ≤2.0 mg/dL Aspartate transaminase (AST) ≤2.5 x upper limit of normal (ULN) Alanine transaminase (ALT) ≤2.5 x ULN Serum creatinine ≤2.0 mg/dL Amylase ≤1.5 x ULN Lipase ≤1.5 x ULN
- •Spirometry indicating a FEV1 of >79% of predicted.
- •Subject must be willing and able to provide written informed consent.
Exclusion Criteria
- •Known central nervous system (CNS) tumor involvement.
- •Evidence of other active malignancy.
- •Active asthma or other chronic lung disease.
- •Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
- •ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
- •Active serious systemic disease, including active bacterial or fungal infection.
- •Chronic inflammatory bowel disease.
- •Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment.
- •Breast-feeding, pregnant, or likely to become pregnant during the study.
- •Active hepatitis or HIV infection.
- •Subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or documented HAHA.
- •Subjects with large ascites (≥500 cc based on results of most recent CT scan).
Investigators
Study Sites (1)
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