CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
CS-1008 (humanized anti-DR5 antibody) +1 moredrug
Likely dose
CS-1008 (humanized anti-DR5 antibody) 8mg/kgfrom 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/NCT00521404
NCT00521404Phase 2Completed

Phase 2 Multicenter, Open-Label Study of CS-1008, A Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), In Combination With Gemcitabine in Chemotherapy Naive Subjects With Unresectable or Metastatic Pancreatic Cancer

Daiichi Sankyo·interventional·Posted Aug 27, 2007·Updated Apr 8, 2021

In Brief

A Phase 2 clinical trial evaluating CS-1008 (humanized anti-DR5 antibody) and gemcitabine for Pancreatic Cancer. Completed, enrolled 65 participants across 12 sites.

Detailed Summary

Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2007
Enrollment StartAug 15, 2007
Primary CompletionAug 20, 2010
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 18.8 years ago

Interventions

CS-1008 (humanized anti-DR5 antibody)drug

CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.

gemcitabinedrug

Gemcitabine - 1000mg/meter sq