CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 217 enrolled
Drug / intervention
OMP-59R5 +3 moredrug
Likely dose
Not stated in 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/NCT01647828
NCT01647828Phase 2Completed
CompareCT.gov

A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

OncoMed Pharmaceuticals, Inc.·interventional·Posted Jul 24, 2012·Updated Feb 15, 2023

In Brief

A Phase 2 clinical trial evaluating OMP-59R5, Gemcitabine, and 2 other interventions for Stage IV Pancreatic Cancer. Completed, enrolled 217 participants across 26 sites.

Detailed Summary

The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage IV pancreatic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage IV Pancreatic Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2012
Enrollment StartOct 1, 2012
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.9 years ago

Interventions

OMP-59R5drug

OMP-59R5 administered intravenously

Gemcitabinedrug

administered intravenously

Placebodrug

administered IV

Nab-Paclitaxeldrug

administered intravenously