Clinical trial · Interventional
Study of Gemcitabine and Abraxane for Pancreas Cancer
A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer
NCT02242409CI-TRIAL-00025955terminatedPhase 2ClinicalTrials.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): Testing of combination no longer relevant
Summary
Brief summary (as posted)
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine and Abraxane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine/abraxane
- description
- Gemcitabine and Abraxane
- interventionNames
- Drug: Gemcitabine and Abraxane
Primary outcomes (1)
- measure
- 4 month progression free survival
- timeFrame
- 2.5 years
- description
- The proportion of patients at 4 months from study entry with progression or death
Secondary outcomes (3)
- measure
- Disease control rate
- timeFrame
- 2.5 years
- description
- Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic adenocarcinoma of the pancreas * Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease * Radiographically measurable or evaluable disease * Age \>/= 18 years * ECOG performance status 0-2 * Adequate hepatic, bone marrow and renal function Exclusion Criteria: * Prior gemcitabine-based chemotherapy in the first line setting * No active severe infection, or known chronic infection with HIV or hepatitis B virus * No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months * No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception * Patients with known CNS metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel * Anticipated patient survival under 2 months
References
Publications (0)
Data not yet available
No reference posted for this study.