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

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ClinicalTrials.gov Identifier: NCT00521404
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Progression-free survival rate at 16 weeks [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Overall Progression-free survival rate [ Time Frame: 16 weeks ]
  2. Overall survival rate [ Time Frame: 16 weeks ]
  3. Duration of progression-free survival [ Time Frame: 16 weeks ]
  4. Best overall response using RECIST criteria [ Time Frame: 16 weeks ]
  5. Treatment-emergent safety events as measured by NCE CTCAE v3.0 [ Time Frame: 16 weeks ]
  6. Pharmacokinetic parameter AUC0-last [ Time Frame: 16 weeks ]
  7. Pharmacokinetic parameter AUC0-1wk [ Time Frame: 16 weeks ]
  8. Pharmacokinetic parameter Cmax [ Time Frame: 16 weeks ]
  9. Pharmacokinetic parameter Cmin,ss [ Time Frame: 16 weeks ]
  10. Pharmacokinetic parameter Tmax [ Time Frame: 16 weeks ]
  11. Pharmacokinetic parameter CL [ Time Frame: 16 weeks ]
  12. Pharmacokinetic parameter Acc [ Time Frame: 16 weeks ]
  13. Pharmacokinetic parameter Vss [ Time Frame: 16 weeks ]
  14. Pharmacokinetic parameter VD [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521404


Locations
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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
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Principal Investigator: Mansoor Saleh, MD Georgia Cancer Specialists

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00521404     History of Changes
Other Study ID Numbers: CS1008-A-U201
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc.:
Pancreatic cancer
chemotherapy naive
unresectable or metastatic pancreatic cancer
CS1008
Gemcitabine
Gemzar
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antibodies
Immunoglobulins
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs