A Study of DMOT4039A in Participants With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer
Completed · Phase 1
Conditions studied: Ovarian Cancer
In brief
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 cancer. Cohorts of participants will receive multiple ascending intravenous doses of DMOT4039A.
Key facts
- Study ID
- NCT01469793
- Run by
- Genentech, Inc.
- People needed
- 71
- Starts
- 2011-11-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2017-01-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Phoenix, Arizona, United States
- Study site — Aurora, Colorado, United States
- Study site — Jacksonville, Florida, United States
- Study site — Rochester, Minnesota, United States
- Study site — Amsterdam, Netherlands
- Study site — Groningen, Netherlands
Full record on ClinicalTrials.gov
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