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A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01103791
First received: April 5, 2010
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.

Condition Intervention Phase
Advanced Solid Malignancies
Drug: Docetaxel-PNP
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • The maximum tolerated dose (MTD) of Docetaxel-PNP [ Time Frame: up to 6 cycle ]
    Administration of docetaxel-PNP was well tolerated up 6mg/m² every 3weeks by heavily pretreated patients.

  • The recommended phase II dose of Docetaxel-PNP [ Time Frame: up to 6 cycle ]
    Futher phase Ⅱ Trials are recommended at this dose level


Secondary Outcome Measures:
  • The Dose Limiting Toxicity (DLT) [ Time Frame: up to 6 cycle ]
  • The pharmacokinetics of Docetaxel-PNP on Day 1 of 1st cycle (AUC, CL, T1/2, Tmax, Cmax, Vdss) [ Time Frame: up to 6 cycle ]
  • Objective response rate [ Time Frame: up to 6 cycle ]

Enrollment: 19
Actual Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Docetaxel-PNP 20mg/m2
Drug: Docetaxel-PNP
Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 2
Docetaxel-PNP 35mg/m2
Drug: Docetaxel-PNP
Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 3
Docetaxel-PNP 45mg/m2
Drug: Docetaxel-PNP
Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 4
Docetaxel-PNP 60mg/m2
Drug: Docetaxel-PNP
Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 5
Docetaxel-PNP 75mg/m2
Drug: Docetaxel-PNP
Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Experimental: Cohort 6
Docetaxel-PNP 90mg/m2
Drug: Docetaxel-PNP
Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient ages more than 18 years old
  • Patient should voluntarily sign a written informed consent before study entry
  • Patient historically or cytologically confirmed diagnosis of advanced solid tumor and patient with measurable disease or evaluable disease by RECIST criteria
  • Progressive disease with development of new lesions or an increase in preexisting lesions or standard therapy in order to provide clinical benefit does not exist or is no longer effective
  • Previous anti-cancer therapies must be completed before 21days of first study dose and Patient must have recovered from any previous therapy
  • Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Patient has a life expectancy of at least 3 months
  • Baseline studies for determining eligibility must be completed within 14 days of first study dose and patient has a adequate organ function including the following:

    • Hb ≥ 10g/dl
    • ANC ≥ 1.5 X 109/L
    • Platelet count ≥ 100 X 109/L
    • Serum total bilirubin ≤ 1.5 mg/dL
    • Serum AST and ALT ≤ 2.5 X UNL
    • Serum ALP ≤ 2.5ⅹUNL
    • Serum creatinine ≤ 1.5 X UNL

Exclusion Criteria:

  • Patient has had a major surgery except tumor ablation within 2 weeks before screening visit
  • Patient has a brain metastasis with neurologic symptom
  • Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE
  • Patient has any serious concurrent disease such as:

Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection.

  • Patient has hypersensitivity to the Investigational product or their excipients
  • Patient has participated in any other clinical trial within 4 weeks before screening visit
  • Woman is pregnant or breast feeding
  • Subjects who are of childbearing potential who do not use a medically acceptable method of birth control or do not agree to continue use of this method throughout the trial (screening, treatment period, and 3 weeks from the last done). A negative pregnancy test (urine or serum) should be documented within 14 days prior to initiation of trial medication for women of childbearing potential who have not been amenorrheic for at least 12 months prior to registration into the trial or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Medically acceptable methods include:

    • Barrier method with spermicide
    • Intrauterine device
    • Complete abstinence, etc.
  • Patient who has a history of resistance, intolerance, or no response to Docetaxel therapy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103791

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Investigators
Principal Investigator: Kyung Hae Jung, Ph. D. Asan Medical Center
  More Information

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01103791     History of Changes
Other Study ID Numbers: DOPNP101
Study First Received: April 5, 2010
Last Updated: May 2, 2017

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017