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

NCT02639858 | Unknown Phase 2

• 1 other identifier: DOCH&N201
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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)

  2 years

Secondary Outcomes (5)

• Progression free survival (PFS)

  2 years

• Disease control rate (DCR)

  2 years

• Overall survival

  2 years

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

  2 years

• Incidence rate of hypersensitivity reaction to Docetaxel-PM

  2 years

Study Arms (1)

Docetaxel-PM

EXPERIMENTAL

Docetaxel-PM 75mg/m2 IV infusion

Drug: Docetaxel-PM

Interventions

Docetaxel-PM DRUG

Docetaxel PM 75mg/m2 IV infusion

Also known as: Nanoxel M

Docetaxel-PM

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Samyang Biopharmaceuticals

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 28, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

KR (1)