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

• ClinicalTrials.gov Identifier: NCT02639858
• Recruitment Status: Recruiting
• First Posted: December 28, 2015
• Last Update Posted: May 1, 2017
• Sponsor: Samyang Biopharmaceuticals Corporation
• Information provided by (Responsible Party): Samyang Biopharmaceuticals Corporation

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• Responsible Party: Samyang Biopharmaceuticals Corporation
• ClinicalTrials.gov Identifier: NCT02639858
• Other Study ID Numbers: DOCH&N201
• First Posted: December 28, 2015
• Last Update Posted: May 1, 2017
• Last Verified: April 2017

Additional relevant MeSH terms:

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