Ovarian Cancer, Pancreatic Cancer Clinical Trial
Official title:
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
| Verified date | November 2016 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 77 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) | Up to 21 days | No | |
| Primary | Nature of dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.0 | Up to 21 days | No | |
| Secondary | Incidence of adverse events | Up to 1 year | No | |
| Secondary | Nature of adverse events graded per NCI CTCAE v4.0 | Up to 1 year | No | |
| Secondary | Severity of adverse events | Up to 1 year | No | |
| Secondary | Area under the concentration-time curve | up to 1 year | No | |
| Secondary | Maximum concentrations | up to 1 year | No | |
| Secondary | Minimum concentrations | up yo 1 year | No | |
| Secondary | Clearance | up to 1 year | No | |
| Secondary | Half-life | up to 1 year | No | |
| Secondary | Volume of distribution | up to 1 year | No |