Clinical trial · Interventional
Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer
A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT00267020CI-TRIAL-00046862completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzastaurin | Drug | Enzastaurin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enzastaurin+Gemcitabine
- interventionNames
- Drug: enzastaurin
- Drug: gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- interventionNames
- Drug: gemcitabine
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Randomization to the date of death from any cause up to 27.7 months
- description
- OS was the duration from randomization to death. OS was censored at the last contact for participants who were alive, at the cut-off date.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDYount S, Cella D, Webster K, Heffernan N, Chang C, Odom L, van Gool R. Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: the FACT Hepatobiliary Symptom Index. J Pain Symptom Manage. 2002 Jul;24(1):32-44. doi: 10.1016/s0885-3924(02)00422-0. PMID 12183093