Ovarian Cancer, Pancreatic Cancer
Conditions
Brief summary
This is a Phase I, multi-center, open-label, dose-escalation study of DMUC5754A administered as a single agent by intravenous (IV) infusion to patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer.
Interventions
DRUGDMUC5754A
Escalating intravenous dose
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Life expectancy of at least 12 weeks * Documented willingness to use an effective means of contraception for women of childbearing potential * Measurable disease with at least one lesion that can be accurately measured in at least one dimension Inclusion Criteria Specific to Patients with Ovarian Cancer: * Advanced, epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months of the most recent treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists * For patients in the dose-expansion cohort of the study only, no more than two prior chemotherapy regimens for the treatment of platinum-resistant ovarian cancer Inclusion Criteria Specific to Patients with Pancreatic Cancer: * Incurable, locally advanced, or metastatic disease for which no standard therapy exists, consisting of unresectable pancreatic ductal adenocarcinoma, including recurrence of previously-resected disease that is considered unresectable with curative intent * No more than one chemotherapy regimen (approved or experimental) administered in the metastatic setting
Exclusion criteria
* Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to Day 1 * Palliative radiation to bone metastases within 2 weeks prior to Day 1 * Major surgical procedure within 4 weeks prior to Day 1 * Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds) * Current Grade \>1 toxicity (except alopecia and anorexia) from prior therapy or Grade \>1 neuropathy from any cause * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and the screening CNS radiographic study is \>= 8 weeks since completion of radiotherapy and \>= 4 weeks since the discontinuation of corticosteroids and anticonvulsants. * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications * Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmias, and unstable angina); nervous system, pulmonary (including obstructive pulmonary disease and history of symptomatic bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLTs) | Up to 21 days |
| Nature of dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.0 | Up to 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Severity of adverse events | Up to 1 year |
| Area under the concentration-time curve | up to 1 year |
| Maximum concentrations | up to 1 year |
| Incidence of adverse events | Up to 1 year |
| Clearance | up to 1 year |
| Half-life | up to 1 year |
| Volume of distribution | up to 1 year |
| Minimum concentrations | up yo 1 year |
| Nature of adverse events graded per NCI CTCAE v4.0 | Up to 1 year |
Countries
United States
Outcome results
None listed