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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

NCT01103791 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-05-05

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Solid Malignancies

Interventions

DRUG

Docetaxel-PNP

Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel

Sponsors & Collaborators

  • Samyang Biopharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Kyung Hae Jung, Ph. D. · Asan Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-09-30
Completion
2012-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103791 on ClinicalTrials.gov