Clinical trial · Interventional
A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer
Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy
NCT01632306CI-TRIAL-00036553terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study has been terminated due to slow enrollment.
Summary
Brief summary (as posted)
Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic 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 Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| LY2090314 | Drug | — | UNRESOLVED |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- LY2090314 + Gemcitabine
- description
- LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m\^2) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
- interventionNames
- Drug: LY2090314
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- LY2090314 + FOLFOX
- description
- LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.
- interventionNames
- Drug: LY2090314
- Drug: FOLFOX
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic pancreatic cancer with metastases amenable to biopsy * Willingness to provide tissue and blood samples for research purposes * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 Exclusion Criteria: * History of islet cell, acinar cell, or cystadenocarcinomas * Prior cytotoxic chemotherapy for metastatic disease, except prior gemcitabine or FOLFIRINOX (5FU + leucovorin + irinotecan + oxaliplatin) * Radiation therapy, immunotherapy or biologic therapy \<28 days prior to study entry
References
Publications (0)
Data not yet available
No reference posted for this study.