A Phase I, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of DMUC5754A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer
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