Phase 2
Completed N=130
Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT00267020 ↗Enrolled (actual)
130
Serious AEs
59.5%
Results posted
Aug 2020
Primary outcomePrimary: Overall Survival (OS) — 5.6; 5.1 months
Summary
The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
5.6; 5.1 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) |
1.2; 0; 7.4; 5.3 | — |
| SECONDARY Progression Free Survival (PFS) |
3.4; 3.0 | — |
| SECONDARY Duration of Response |
4.6; 9.2 | — |
| SECONDARY Change in Scores From Baseline (Improved, Stable or Worsened) to End of Study in Functional Assessment of Cancer Therapy Hepatobiliary Version 4 ( FACT-Hep v.4) (Quality of Life (QOL)) |
7.2; 6.5; 0.3; 0.8; -10.0; -7.8 | — |
| SECONDARY Relationship of Steady-State Drug Levels to Clinical Outcomes of Overall Survival (OS) |
7.2; 5.6 | — |
| SECONDARY Relationship of Steady-state Drug Levels to Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Disease Control) |
3.6; 0.0; 17.9; 3.6; 57.1; 39.3 | — |
| SECONDARY Carbohydrate Antigen 19-9 (CA 19-9) Concentration in the Blood |
31708.5; 12038.6; 12828.4; 40764.9; 24709.5; 1573.0 | — |
| SECONDARY Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) (Toxicity) |
80; 38; 49; 23; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of adenocarcinoma of the pancreas.
- Pretreatment tumor specimen must be available.
- No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy.
- Prior radiation allowed.
- Ability to stop some types of anti-seizure medicines within 14 days of enrollment.
Exclusion Criteria
- Endocrine pancreatic tumor or ampullary cancer.
- Central Nervous System (CNS) metastases.
- Inability to swallow tablets.
- 10% or greater weight loss over the 6 weeks before study entry.
Data sourced from ClinicalTrials.gov (NCT00267020). 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.