Clinical trial NCT00521404: Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
chemotherapy naive
unresectable or metastatic pancreatic cancer
CS1008
Gemcitabine
Gemzar
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2007-08-27
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
timeFrame: Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.
Secondary outcomes:
measure: Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
timeFrame: Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.
measure: Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
timeFrame: Baseline to death due to any cause, up to approximately 36 months post dose.
measure: Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
timeFrame: Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.
measure: Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term
timeFrame: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
measure: Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term
timeFrame: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Washington
country: United States
state: District of Columbia
city: Fort Myers
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Tucker
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Decatur
country: United States
state: Illinois
city: Minneapolis
country: United States
state: Minnesota
city: Cincinnati
country: United States
state: Ohio
city: Chattanooga
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Temple
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: