Open-label Study of CS1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00521404
First received: August 24, 2007
Last updated: October 27, 2010
Last verified: October 2010
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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
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 May 23, 2013