ZOvCa: A phase 1 Positron Emission Tomography (PET) - Computed Tomography (CT) study to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 in patients with advanced epithelial Ovarian Cancer
- Conditions
- Advanced epithelial ovarian cancerCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12624000469516
- Lead Sponsor
- Mater Misericordiae Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 30
• Adults (equal or greater than 18 years) with recurrent, histologically proven advanced ovarian cancer.
• Macroscopically visible tumour on diagnostic CT with contrast and FDG-PET/CT imaging.
• CDCP1 expression proven on tumour sample.
• ECOG 0-1
• Expected survival more than 3 months
• Adequate organ function. Out of range values that are not clinically significant will be permitted, except for the following laboratory parameters, which must be within the ranges specified: Serum AST and ALT (acceptable range less than or equal to 2.5 x ULN) and Serum bilirubin (acceptable range less than or equal to 1.5 x ULN)
• Use of anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, or any investigational therapy within 28 days prior to administration of 89Zr-hu/mo-10D7.
• History of major immunologic reaction to any IgG containing agent.
• Medical condition(s) which places the subject at an unacceptably high risk.
• Subject is pregnant, lactating, or unwilling/unable to use adequate contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method