Clinical trial · Interventional
Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer
A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
NCT00813163CI-TRIAL-00040418completedPhase 2ClinicalTrials.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 study is to see the effect of PEP02 in the treatment of 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 Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP02 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEP02
- description
- Liposome Irinotecan
- interventionNames
- Drug: PEP02
Primary outcomes (1)
- measure
- Survival Rate
- timeFrame
- 3-month
- description
- Survival rate at 3 months
Secondary outcomes (3)
- measure
- other efficacy endpoints
- timeFrame
- 6-8 weeks
- description
- objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas * Metastatic disease * Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen * Karnofsky performance status equal or more than 70 Exclusion Criteria: * With active CNS metastases * With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea \> grade 1) * Major surgery or radiotherapy within 4 weeks * Prior participation in any investigational drug study within 4 weeks * With prior irinotecan treatment
References
Publications (1)
- DERIVEDKo AH, Tempero MA, Shan YS, Su WC, Lin YL, Dito E, Ong A, Wang YW, Yeh CG, Chen LT. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):920-5. doi: 10.1038/bjc.2013.408. Epub 2013 Jul 23. PMID 23880820