Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

Daiichi Sankyo

Status and phase

Completed

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: CS-1008 (humanized anti-DR5 antibody)

Drug: gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00521404

CS1008-A-U201

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older

Exclusion criteria

Anticipation of need for major surgery or radiation therapy during the study
Heart Disease exclusions: myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
Clinically significant active infection or history of HIV
Partial or complete bowel obstruction
Poorly controlled psychiatric illness