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Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of Oral Paclitaxel in Patients With Advanced Solid Cancer

NCT01491204 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2011-12-13

No results posted yet for this study

Summary

The main objective of this study is to determine the maximum tolerated dose (MTD) of Oral Paclitaxel. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy.

Administration Schedule: 1 cycle of Oraxol®(paclitaxel+HM30181A) medication was 28 days and Oraxol® was administrated total 3 times once a week (day 1, 8, 15). The next cycle started on day 29.

Methods of Administration: HM30181A tablet was administered 1hour prior to the medication of paclitaxel

Conditions

Interventions

DRUG

Paclitaxel+HM30181

oral, 3times for 4weeks

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

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Entities

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 NCT01491204 on ClinicalTrials.gov