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Head and Neck NeoplasmsPhase 1NCT02817113

Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer

A Phase 1 study testing NC-6004, Cetuximab and 5-FU in people with Head and Neck Neoplasms, run by Orient Europharma Co., Ltd. at 3 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
NC-6004, Cetuximab and 5-FU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
3 sitesTaiwan
Study dates
Jun 2016to Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital, Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: 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

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.

Read the detailed description
  1. Primary objectives ♦ To determine the Maximum Tolerated Dose (MTD) of NC-6004 according to the Dose Limiting Toxicity (DLT) in combination with 5-FU plus cetuximab as firstline treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), and to decide the RD for the following studies
  2. Secondary objectives 1). To evaluate the safety and tolerability profile of NC-6004 in combination with 5- FU plus cetuximab 2). To assess the pharmacokinetic effects of NC-6004 3). To assess the antitumor effects of NC-6004
Being tested
NC-6004, Cetuximab, 5-FU
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NC-6004Drug

    Also called Micelplatin (Taiwan only), Nanoplatin (Japan only)

    One cycle of treatment lasts for 3 weeks. NC-6004 will be administered over 1 hour on Day 1 (after the cetuximab infusion) every 3 weeks

  • CetuximabDrug

    Also called Erbitux

    One cycle of treatment lasts for 3 weeks. For each cycle, cetuximab will be administered at least 1 hour before the start of chemotherapy at a loading dose of 400 mg/m2 given over 2 hours initially (ie, on the first day of treatment), followed by a subsequent weekly doses of 250 mg/m2 over 1 hour.

  • 5-FUDrug

    Also called Fluorouracil

    One cycle of treatment lasts for 3 weeks. 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.

Study groups in NCT02817113
Study groupRoleWhat they receive
NC-6004, Cetuximab and 5-FUExperimentalCetuximab 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.
Receives: Drug: NC-6004; Drug: Cetuximab; Drug: 5-FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    MTD of NC-6004 according to the DLT when administered in combination with 5-FU plus cetuximab as first-line treatment

    Measured: 29 months

Secondary outcomes (15)

  1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 criteria

    Measured: 29 months

  2. Incidence of AE lead to treatment discontinuation

    Measured: 29 months

  3. Peak Plasma Concentration (Cmax)

    Measured: Within 4 cycles (each cycle is 21 days)

  4. Time of Maximum concentration observed (Tmax)

    Measured: Within 4 cycles (each cycle is 21 days)

  5. Area under the plasma concentration-time curve from time zero to time (AUC0-t)

    Measured: Within 4 cycles (each cycle is 21 days)

  6. Area under the concentration time-curves from time zero to infinity (AUC0-∞)

    Measured: Within 4 cycles (each cycle is 21 days)

  7. Terminal Elimination Rate Constant (λz)

    Measured: Within 4 cycles (each cycle is 21 days)

  8. Elimination Half-life (t½)

    Measured: Within 4 cycles (each cycle is 21 days)

  9. Clearance (CL) of total platinum in plasma

    Measured: Within 4 cycles (each cycle is 21 days)

  10. Clearance (CL) of total platinum in plasma ultrafiltrate

    Measured: Within 4 cycles (each cycle is 21 days)

  11. Volume of Distribution (Vz) of total platinum in plasma

    Measured: Within 4 cycles (each cycle is 21 days)

  12. Volume of Distribution (Vz) of total platinum in plasma ultrafiltrate

    Measured: Within 4 cycles (each cycle is 21 days)

  13. Tumor response rate (RR)

    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results

    Measured: 29 months

  14. Disease control rate (DCR)

    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results

    Measured: 29 months

  15. Overall response rate (ORR)

    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results

    Measured: 29 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionSep 2018
  4. Study completionSep 2018

Why it stopped: Strategy change

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817113
Sponsor's protocol ID
NC-6004-006
Status last verified
Apr 2021
First submitted
6 Jun 2016
Last updated
30 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NC-6004, Cetuximab and 5-FU in people with Head and Neck Neoplasms, run by Orient Europharma Co., Ltd. at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategy change). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: 29 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.

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