CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
MORAb-009 +2 moredrug
Likely dose
Gemcitabine 1000 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00570713
NCT00570713Phase 2Completed
CompareCT.gov

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.

Morphotek·interventional·Posted Dec 11, 2007·Updated Sep 9, 2015

In Brief

A Phase 2 clinical trial evaluating MORAb-009, Placebo, and 1 other intervention for Pancreatic Cancer. Completed, enrolled 155 participants across 45 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesBelgium, Canada, Germany, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2007
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.6 years ago

Interventions

MORAb-009drug

Monoclonal antibody administered once weekly by intravenous injection.

Placebodrug

As per package insert.

Gemcitabinedrug

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.