A Study of DMOT4039A in Patients With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer

Status:	Completed
Conditions:	Ovarian Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	8/3/2016
Start Date:	November 2011
End Date:	December 2015

A Phase I, Open Label Study of the Safety and Pharmacokinetics of Escalating Doses of DMOT4039A in Patients With Unresectable Pancreatic or Platinum Resistant Ovarian Cancer

This multicenter, open-label, dose-escalating study will assess the safety and efficacy of
DMOT4039A in patients with unresectable pancreatic or platinum-resistant ovarian cancer.
Cohorts of patients will receive multiple ascending intravenous doses of DMOT4039A.
Anticipated time on study treatment is up to 1 year or until disease progression occurs.

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Histologically documented, incurable, locally advanced or metastatic disease for
which no standard therapy exists, consisting of one of the following: Unresectable
pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer

- Measureable disease, defined as at least one bi-dimensionally measurable non-lymph
node lesion >/= 1 cm in long-axis diameter on spiral CT scan or at least one
bi-dimensionally measurable lymph node measuring >/= 1.5 cm in short-axis diameter on
spiral CT scan

- Adequate hematological, renal and liver function

Exclusion Criteria:

- Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or
hormonal therapy, within 4 weeks prior to Day 1

- Known active infection

- Current Grade >/= 2 toxicity (except for alopecia, anorexia and fatigue) from prior
therapy or Grade >/= 2 neuropathy

- Untreated or active cerebral nervous system (CNS) metastases

- Pregnant or breastfeeding women

We found this trial at

sites

Clinical Trial Facility in Jacksonville Florida

Jacksonville, Florida 32209

from

Jacksonville, FL