Phase 2 N=62 Treatment

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

Pancreatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00521404 ↗

Enrolled (actual)

Serious AEs

56.5%

Results posted

Dec 2020

Primary outcome: Primary: 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 — 52.5 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CS-1008 (humanized anti-DR5 antibody) (Drug); gemcitabine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Daiichi Sankyo
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	52.5	—
SECONDARY 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	59.0; 34.4; 21.3; 13.1	—
SECONDARY Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer	55.7; 41.0; 24.6; 13.1	—
SECONDARY Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer	0; 5; 5; 0; 3; 28	—
SECONDARY 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	43; 8; 4; 5; 5; 8	—
SECONDARY 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	54; 15; 4; 5; 11; 4	—

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.

Eligibility 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

Anticipation of 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.
Clinically significant active infection or history of HIV
Partial or complete bowel obstruction
Poorly controlled psychiatric illness

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00521404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.