Clinical trial · Interventional
NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries
NCT00910741CI-TRIAL-00013369completedPhase 1 / Phase 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 determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.
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 |
|---|---|---|---|
| Locally Advanced and Metastatic Pancreatic Cancer | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nanoplatin (NC-6004) and Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nanoplatin
- description
- Nanoplatin (NC-6004) had to be administered once every 3 weeks, on Day 1, Day 22 and Day 43 etc. Gemcitabine had to be administered to every patient 2 times on Day 1 and Day 8 every 3 weeks after the infusion of Nanoplatin (NC-6004).
- interventionNames
- Drug: Nanoplatin (NC-6004) and Gemcitabine
Primary outcomes (1)
- measure
- Incidence of DLT and Response rate
- timeFrame
- DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 1.5 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with chemo-naive, advanced pancreatic cancer * Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer Exclusion Criteria: * Pulmonary fibrosis or interstitial pneumonia * Marked pleural effusion or ascites above Grade 2 * Severe drug hypersensitivity * Metastasis to the central nervous system and brain
References
Publications (1)
- BACKGROUNDUchino H, Matsumura Y, Negishi T, Koizumi F, Hayashi T, Honda T, Nishiyama N, Kataoka K, Naito S, Kakizoe T. Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of cisplatin in rats. Br J Cancer. 2005 Sep 19;93(6):678-87. doi: 10.1038/sj.bjc.6602772. PMID 16222314