Clinical trial · Interventional
Gemcitabine and Oxaliplatin (Gem-Ox) Plus Glivec in Gemcitabine-refractory Pancreatic Cancer
A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate (Glivec) in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas
NCT01048320CI-TRIAL-00008133RPGOG1completedPhase 1ClinicalTrials.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 main research objective is to work out the optimal doses of the novel combination of gemcitabine, oxaliplatin and imatinib mesylate (glivec) in patients with advanced pancreatic cancer that has progressed during or after treatment with first-line gemcitabine.
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 |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Imatinib | Drug | Imatinib | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- Gemcitabine plus Oxaliplatin in combination with imatinib mesylate
- interventionNames
- Drug: Gemcitabine
- Drug: Oxaliplatin
- Drug: Imatinib
Primary outcomes (1)
- measure
- The primary outcome measure for the study is to establish the Maximum Tolerated Dose of the drug regimen based on the endpoint of dose-limiting toxicity
- timeFrame
- 1 year
Secondary outcomes (4)
- measure
- Progression free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 18 years * gemcitabine-refractory, histologically confirmed pancreatic cancer (progression during or within 6 months of first-line treatment) * locally advanced or metastatic disease with measurable or non-measurable disease * life expectancy of greater than 10 weeks * prior treatment with investigational therapies including EGFR and VEGF antagonists is allowed when administered\>4 weeks prior to start of therapy Exclusion Criteria: * any serious uncontrolled medical condition * prior radiation treatment is not allowed * no prior chemotherapy within the previous 4 weeks * known peripheral neuropathy \> CTCAE v 3.0 grade 1; absence of the deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible * known brain metastases * lack of physical integrity of the upper GI tract, malabsorption syndrome, or inability to take oral medication * fertile women (\<2 years after last menstruation) and men of childbearing potential not willing to use effective contraception * pregnancy or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.