Open-label Study of CS1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00521404
First received: August 24, 2007
Last updated: October 27, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: CS-1008 (humanized anti-DR5 antibody)
Drug: gemcitabine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Progression-free survival rate at 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival rate; overall survival rate; Duration of progression-free survival; overall survival; best overall response using RECIST criteria; Analysis of pharmacokinetics; analysis of safety as measured by NCE CTCAE v3.0 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-1008 + gemcitabine
CS-1008 + gemcitabine
Drug: CS-1008 (humanized anti-DR5 antibody)
CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
Other Name: CS1008
Drug: gemcitabine
Gemcitabine - 1000mg/meter sq
Other Name: Gemzar

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 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521404

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Fort Myers, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Georgia Cancer Specialists
Tucker, Georgia, United States, 30084
United States, Illinois
Decatur, Illinois, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Temple, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Principal Investigator: Mansoor Saleh, MD Georgia Cancer Specialists
  More Information

No publications provided

Responsible Party: Wojtowicz-Praga, Slawomir, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00521404     History of Changes
Other Study ID Numbers: CS1008-A-U201
Study First Received: August 24, 2007
Last Updated: October 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Pancreatic cancer
chemotherapy naive
unresectable or metastatic pancreatic cancer
CS1008
Gemcitabine
Gemzar

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies
Gemcitabine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014