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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Ovarian Cancer, Pancreatic Cancer

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Up to 21 days

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

DGR4980g

NCT ID:

NCT01335958

Start Date:

April 2011

Completion Date:

March 2015

Related Keywords:

  • Ovarian Cancer, Pancreatic Cancer
  • Ovarian Neoplasms
  • Pancreatic Neoplasms

Name

Location

Nashville, Tennessee  37203-1632
Boston, Massachusetts  
Tulsa, Oklahoma