Status:
COMPLETED
A Study of DMOT4039A in Participants With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This multicenter, open-label, dose-escalating study will assess the safety, tolerability, and pharmacokinetics of DMOT4039A in participants with unresectable pancreatic or platinum-resistant ovarian c...
Eligibility Criteria
Inclusion
- 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 greater than or equal to (\>/=) 1 centimeter (cm) in long-axis diameter on spiral computed tomography (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
- 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 metastases
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01469793
Start Date
November 1 2011
End Date
December 1 2015
Last Update
January 10 2017
Active Locations (6)
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1
Phoenix, Arizona, United States, 85259
2
Aurora, Colorado, United States, 80045
3
Jacksonville, Florida, United States, 32224
4
Rochester, Minnesota, United States, 55905