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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


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

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 1 year

Safety Issue:

No

Principal Investigator

Daniel Maslyar, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

DMO4993g

NCT ID:

NCT01469793

Start Date:

November 2011

Completion Date:

August 2015

Related Keywords:

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

Name

Location

Alexandria, Minnesota  56308
Phoenix, Arizona  85012
Miami, Florida  33176
Denver, Colorado