Trials / Completed
CompletedNCT00570713
An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
A Phase 2 Randomized, Placebo-controlled, Double-blind Study of the Efficacy of MORAb-009 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 155 (actual)
- Sponsor
- Morphotek · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the activity of MORAb-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MORAb-009 | Monoclonal antibody administered once weekly by intravenous injection. |
| DRUG | Placebo | As per package insert. |
| DRUG | Gemcitabine | Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2007-12-11
- Last updated
- 2015-09-09
- Results posted
- 2012-03-27
Locations
45 sites across 5 countries: United States, Belgium, Canada, Germany, Spain
Source: ClinicalTrials.gov record NCT00570713. Inclusion in this directory is not an endorsement.