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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639858
Recruitment Status : Recruiting
First Posted : December 28, 2015
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

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

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Docetaxel-PM Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Docetaxel-PM
Docetaxel-PM 75mg/m2 IV infusion
Drug: Docetaxel-PM
Docetaxel PM 75mg/m2 IV infusion
Other Name: Nanoxel M




Primary Outcome Measures :
  1. Response rate as assessed by RECIST v1.1 [ Time Frame: 2 years ]
    Response is confirmed at least 4 weeks later. Assessment: every 6 weeks (treatment period), every 2 months (follow-up period)


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 2 years ]
    Assessment: every 2 months (follow-up period)

  2. Disease control rate (DCR) [ Time Frame: 2 years ]
    DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease

  3. Overall survival [ Time Frame: 2 years ]
    Assessment: every 2 months (follow-up period)

  4. Number of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
  5. Incidence rate of hypersensitivity reaction to Docetaxel-PM [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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

  3. Patients who aged 20 years or older and under 79 years old
  4. Patients whose Eastern Cooperative Oncology Group (ECOG) performance scores are 0-2
  5. Patients who have one measurable lesion at least by RECIST criteria 1.1
  6. 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
  7. Patients who have signed written consent forms prior to participation in the clinical trial

Exclusion Criteria:

  1. Patients who have Primary tumor of nasopharynx
  2. Patients who have received treatment prior regimen of three or more drugs
  3. 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)
  4. Previous radiotherapy is allowed, patients who should be completed radiotherapy before 4 weeks prior to the initial administration of the investigational product
  5. 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
  6. Patients who have severe diseases or medical condition as follows

    • 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
  7. Pregnant or lactating women
  8. Patients considered inappropriate to participating the study by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639858


Locations
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Korea, Republic of
Samyang Biopharmaceuticals Recruiting
Seoul, Korea, Republic of
Contact: Miryung Jin    +82-2-740-7289    miryung.jin@samyang.com   
Principal Investigator: Sung Bae Kim         
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
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Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT02639858    
Other Study ID Numbers: DOCH&N201
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action