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Head and Neck Squamous Cell CarcinomaPhase 2NCT02639858

Study to Evaluate the Efficacy and Safety of Docetaxel Polymeric Micelle (PM) in Recurrent or Metastatic HNSCC

A Phase 2 study testing Docetaxel-PM in people with Head and Neck Squamous Cell Carcinoma, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or metastatic head and neck squamous cell carcinoma Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Docetaxel-PM
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSouth Korea
Study dates
Oct 2015to Sep 2020
Phase
Phase 2
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who were histologically or cytologically diagnosed as having oral cavity, oropharynx, hypopharynx, or larynx squamous cell carcinoma with recurrent and metastatic evidence and who cannot be treated by salvage surgery or radiotherapy
  • Time of disease progression, regardless of whether that treatment or after platinum-based therapy
  • ①Patients who have disease progression after concurrent chemoradiotherapy of curative purpose (including induction chemotherapy) including a platinum-based (cisplatin or carboplatin) chemotherapy
  • ② Patients who have disease progression after primary or secondary treatment of palliative purpose including a platinum-based (cisplatin or carboplatin) chemotherapy
  • Patients who aged 20 years or older and under 79 years old
  • Patients whose Eastern Cooperative Oncology Group (ECOG) performance scores are 0-2
Show all 13Show fewer
  • Patients who have one measurable lesion at least by RECIST criteria 1.1
  • Patients who show adequate function of organ:
  • bone marrow: Absolute Neutrophil count (ANC) ≥ 1,500/μL, Platelet count ≥ 100,000/μ, Hb≥ 9.0 g/dl (allowed blood transfusion)
  • Liver: ① with no evidence of liver metastasis; Total bilirubin ≤ 1.5mg/dl, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT) ≤ 2.0 X upper limit of normal (ULN)
  • ② with liver metastasis; bilirubin ≤ 3.0 X ULN, aspartate transaminase (AST), alanine transaminase (ALT) ≤ 5.0 X ULN
  • Kidney: creatinine ≤ 1.5 X ULN
  • Patients who have signed written consent forms prior to participation in the clinical trial

Who cannot join

  • Patients who have Primary tumor of nasopharynx
  • Patients who have received treatment prior regimen of three or more drugs
  • Patients who have Primary malignant tumors of other sites (except if; early cervical cancer, skin basal cell cancer received appropriate treatment, Malignant tumor without recurrent state treated five years previously)
  • Previous radiotherapy is allowed, patients who should be completed radiotherapy before 4 weeks prior to the initial administration of the investigational product
  • Patients who have received a major surgery within 4 weeks prior to the initial administration of the investigational product or patients who does not recover after major surgery
  • Patients who have severe diseases or medical condition as follows
Show all 18Show fewer
  • Congestive heart failure(NYHA class III or IV)
  • Unstable angina, cardiac infarction within 6 months
  • Second-degree atrioventricular (AV) block or more, clinically cardiac arrhythmia that needs drug therapy
  • Uncontrollable Hypertension
  • Hepatic cirrhosis (≥ Child class B)
  • Interstitial lung disease
  • Mental disorder not to comply with the protocol
  • Uncontrolled diabetes
  • Uncontrolled ascites or pulmonary edema
  • Active infection
  • Pregnant or lactating women
  • Patients considered inappropriate to participating the study by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Samyang Biopharmaceuticals

    Seoul

    Miryung Jin, +82-2-740-7289, miryung.jin@samyang.com

    Sung Bae Kim

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase II Study to Evaluate the Efficacy and Safety of Docetaxel-PM in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or metastatic head and neck squamous cell carcinoma

Being tested
Docetaxel-PM
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • Docetaxel-PMDrug

    Also called Nanoxel M

    Docetaxel PM 75mg/m2 IV infusion

Study groups in NCT02639858
Study groupRoleWhat they receive
Docetaxel-PMExperimentalDocetaxel-PM 75mg/m2 IV infusion
Receives: Drug: Docetaxel-PM

What is being measured

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

  1. Response rate as assessed by RECIST v1.1

    Response is confirmed at least 4 weeks later. Assessment: every 6 weeks (treatment period), every 2 months (follow-up period)

    Measured: 2 years

Secondary outcomes (5)

  1. Progression free survival (PFS)

    Assessment: every 2 months (follow-up period)

    Measured: 2 years

  2. Disease control rate (DCR)

    DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease

    Measured: 2 years

  3. Overall survival

    Assessment: every 2 months (follow-up period)

    Measured: 2 years

  4. Number of participants with adverse events as assessed by CTCAE v4.0

    Measured: 2 years

  5. Incidence rate of hypersensitivity reaction to Docetaxel-PM

    Measured: 2 years

Timeline

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

  1. First posted28 Dec 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2020 (estimated)
  4. Study completionSep 2020 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02639858
Sponsor's protocol ID
DOCH&N201
Status last verified
Apr 2017
First submitted
14 Dec 2015
Last updated
1 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel-PM in people with Head and Neck Squamous Cell Carcinoma, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.

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 13 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate as assessed by RECIST v1.1 (time frame: 2 years). 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 NCT02639858.

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 1 May 2017.

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