Know Cancer

or
forgot password

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 SpecialistsDecatur, 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