Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer

April 20, 2012 updated by: Taiho Pharmaceutical Co., Ltd.

A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer

The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • East 34th Street, New York, New York, United States, NY 10016
        • NYU Cancer Institute
    • Texas
      • Holcombe Boulevard, Houston, Texas, United States, TX 77030
        • The University of Texas M.D. Anderson Cancer Center
      • West Magnolia Avenue, Fort Worth, Texas, United States, TX 76104
        • The Center for Cancer and Blood Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma
  • Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan
  • Have at least one measurable tumor, as defined by RECIST
  • Must be capable of maintaining a central venous line access

Exclusion Criteria:

  • Had previous anti-tumor therapy in the 3 weeks prior to study entry
  • Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry
  • Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
TAS-109
Drug: TAS-109

14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period.

Number of cycles: until unacceptable toxicity or disease progression requires discontinuation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Progression Free Survival
Time Frame: From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.
The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.
From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antitumor Activity
Time Frame: From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.
Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.
From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.
Overall Survival
Time Frame: From the initial treatment until 12 months after enrollment of the last patient.
Overall survival is defined as the period from the date of first dose of TAS-109 to death date.
From the initial treatment until 12 months after enrollment of the last patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Henry Xiong, M.D., Ph.D., The Center for Cancer and Blood Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (ESTIMATE)

January 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 20, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAS109-0403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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