Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

NCT00521404 | Completed Phase 2 Results

• 1 other identifier: CS1008-A-U201
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 12

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; chemotherapy naive; unresectable or metastatic pancreatic cancer; CS1008; Gemcitabine; Gemzar

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer

  Progression-free survival rate (PFS) was defined as the time from the date of the first administration of the study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first at 16 weeks post-treatment with CS-1008.

  Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.

Secondary Outcomes (5)

• Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer

  Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.

• Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer

  Baseline to death due to any cause, up to approximately 36 months post dose.

• Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer

  Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.

• Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term

  Baseline up to 30 days post last dose, up to approximately 36 months post dose.

• Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term

  Baseline up to 30 days post last dose, up to approximately 36 months post dose.

Study Arms (1)

CS-1008 + gemcitabine

EXPERIMENTAL

CS-1008 + gemcitabine

Drug: CS-1008 (humanized anti-DR5 antibody); Drug: gemcitabine

Interventions

CS-1008 (humanized anti-DR5 antibody) DRUG

CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.

Also known as: CS1008

CS-1008 + gemcitabine

gemcitabine DRUG

Gemcitabine - 1000mg/meter sq

Also known as: Gemzar

CS-1008 + gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older

You may not qualify if:

• Anticipation of need for major surgery or radiation therapy during the study
• Clinically significant active infection or history of HIV
• Partial or complete bowel obstruction
• Poorly controlled psychiatric illness

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (12)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Georgia Cancer Specialists

Tucker, Georgia, 30084, United States

Location

Unknown Facility

Decatur, Illinois, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Temple, Texas, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

tigatuzumab; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: August 15, 2007
• Primary Completion: August 20, 2010
• Study Completion: August 20, 2010
• Last Updated: April 8, 2021
• Results First Posted: December 3, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)