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Docetaxel Lipid Microsphere (DT-LM) for Injection in Chemotherapy Patients

NCT01611961 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2014-09-30

No results posted yet for this study

Summary

Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects of DT-LM compared to commerical docetaxel.

Conditions

Interventions

DRUG

DT-LM

Intravenous infusion, Upto 6 dose levels have been studied i.e. 45, 60, 75, 90 105,and 120 mg/m2, Every 3 weeks.

DRUG

docetaxel

Intravenous infusion, 3 dose levels：60, 75, and 90 mg/m2, Every 3 weeks

Sponsors & Collaborators

  • Shenyang Pharmaceutical University

    lead OTHER

Principal Investigators

  • Xing Tang, Ph.D · Shenyang Pharmaceutical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT01611961 on ClinicalTrials.gov