Trials / Completed
CompletedNCT00521404
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Primary Objective: \- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks. Secondary Objectives: * To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response, and overall survival. * To determine the pharmacokinetics of BIP CS-1008 and DSC CS-1008. * To study potential biomarkers of CS-1008 activity * To assess possible human anti-human antibody formation after exposure to CS-1008 * To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CS-1008 (humanized anti-DR5 antibody) | CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly. |
| DRUG | gemcitabine | Gemcitabine - 1000mg/meter sq |
Timeline
- Start date
- 2007-08-15
- Primary completion
- 2010-08-20
- Completion
- 2010-08-20
- First posted
- 2007-08-27
- Last updated
- 2021-04-08
- Results posted
- 2020-12-03
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00521404. Inclusion in this directory is not an endorsement.