Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of MORAb-003 in Subjects With Advanced Ovarian Cancer
Lead Sponsor:
Morphotek
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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 1.
- 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
- 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).
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00428766
Start Date
June 1 2005
End Date
December 1 2007
Last Update
November 6 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021