Clinical trial · Interventional
Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer
Phase I Study of NC-6004 in Combination With 5-FU and Cetuximab as First-line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategy change
Summary
Brief summary (as posted)
NC-6004 is a polymeric micelle containing cisplatin as an active moiety. The nanoparticle provides sustained release of the active moiety and utilizes the enhanced permeability and retention (EPR) effect to target release of platinum to tumors. This Phase I study aims to establish a recommended dose (RD) for the triplet combination of NC-6004 plus 5-FU and cetuximab as first-line treatment in patient with recurrent and/or metastatic squamous cell carcinoma of the head and neck for further clinical study development.
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 |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| NC-6004 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NC-6004, Cetuximab and 5-FU
- description
- Cetuximab will be administered before the start of chemotherapy at a loading dose of 400 mg/m2 given, followed by a subsequent weekly doses of 250 mg/m2; NC-6004 will be administered on Day 1 every 3 weeks, and 5-FU will be administered at a dose of 1,000 mg/m2/day on Day 1- Day 4 as continuous infusion every 3 weeks.
- interventionNames
- Drug: NC-6004
- Drug: Cetuximab
- Drug: 5-FU
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 29 months
- description
- MTD of NC-6004 according to the DLT when administered in combination with 5-FU plus cetuximab as first-line treatment
Secondary outcomes (15)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Known (histology/cytology proven) or evidenced by radiology of recurrent and/or metastatic SCCHN not suited for local therapy * Males or females aged ≥ 20 years and \< 75 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Life expectancy \>12 weeks as judged by investigators * Adequate bone marrow reservation: * Adequate liver function: * Adequate renal function: * Reasonably recovered from preceding major surgery as judged by the Investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment Exclusion Criteria: * Female of child-bearing potential who is or has intention to be pregnant or breastfeeding. * Previous radiotherapy within 3 months before study entry * Known brain metastasis or leptomeningeal involvement * Marked pleural effusion or ascites above Grade 2, based on NCI-CTCAE v4.03 criteria * History of thrombocytopenia with complications (including hemorrhage or bleeding ≥ Grade 2, based on NCI-CTCAE v4.03 criteria), hemolytic condition, or coagulation disorders that would make subjects unsafe based on the judgment of the Investigator * Patients who have unresolved toxicity from all radiation, adjuvant/neoadjuvant chemotherapy, other targeted treatment including investigational treatment (exception of alopecia and ≤ Grade 2 peripheral neuropathy) according to NCI-CTCAE v4.03 criteria * Known hypersensitivity to the study drugs or the drugs with similar chemical structures * History of myocardial infarction within 6 months before study entry, unstable congestive heart failure (New York Heart Association, NYHA Stage III-IV), angina pectoris, or transient ischemic attack or cardiac arrhythmia requiring medical therapy * History of any other cancer other than head and neck cancer (HNC) (except carcinoma in situ of the cervix) within the last 5 years. * Primary tumor of the nasopharynx (nasopharyngeal carcinoma) * Known HIV-1 or any active infection requiring IV antibiotics
References
Publications (0)
Data not yet available