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Phase I Study of TAS-106 in Combo With Carboplatin

NCT00752011 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-10-18

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest safe dose of the combination of TAS-106 and carboplatin that can be given to patients with advanced cancer or cancer that has spread.

Objectives:

Primary Objectives:

To determine the maximum tolerated dose (MTD) of the combination of TAS-106 and carboplatin administered by intravenous infusion every 3 weeks.

To perform Pharmacokinetic (PK) analysis of TAS-106 and carboplatin

Secondary objectives:

To assess the antitumor activity of TAS-106 combined with carboplatin

To investigate the relationship between selected biomarkers and efficacy and safety outcomes.

Conditions

Interventions

DRUG

TAS-106

Starting dose 2.0 mg/m\^2 by vein over 24 hours, Day 1 of 3 Week Cycle.

DRUG

Carboplatin

Starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle.

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Aung Naing, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00752011 on ClinicalTrials.gov