Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer chemotherapy naive unresectable or metastatic pancreatic cancer CS1008 Gemcitabine Gemzar
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 65
Healthy volunteers: no

Brief 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.

Arms:
arm 1: CS-1008 + gemcitabine

Interventions: intervention 1: CS-1008 (humanized anti-DR5 antibody) intervention 2: gemcitabine
Intervention descriptions: intervention 1: CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly. intervention 2: Gemcitabine - 1000mg/meter sq

Protocol document: