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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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 rate 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 C-1008 and gemcitabine

- To study potential biomarkers of CS-1008 activity

- To evaluate the safety profile of CS-1008 when administered in combination with
gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic
cancer.


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:

- No anticipated 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.

- No clinically significant active infection or history of HIV

- No partial or complete bowel obstruction

- Cannot have poorly controlled psychiatric illness

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 16 weeks

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Mansoor Saleh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgia Cancer Specialists

Authority:

United States: Food and Drug Administration

Study ID:

CS1008-A-U201

NCT ID:

NCT00521404

Start Date:

August 2007

Completion Date:

December 2008

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic cancer
  • chemotherapy naive
  • unresectable or metastatic pancreatic cancer
  • CS1008
  • Gemcitabine
  • Gemzar
  • Pancreatic Neoplasms

Name

Location
Hinsdale, Illinois  60521
Georgia Cancer Specialists Decatur, Georgia  30033
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Miami, Florida  33176
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
McLean, Virginia  22101
Washington, District of Columbia