Phase 2
Completed N=62
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
Source: ClinicalTrials.gov NCT00521404 ↗Enrolled (actual)
62
Serious AEs
56.5%
Results posted
Dec 2020
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.