search
Back to results

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

Primary Purpose

Advanced Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TAS-109
Sponsored by
Taiho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Cancer Institute
  • The University of Texas M.D. Anderson Cancer Center
  • The Center for Cancer and Blood Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

TAS-109

Outcomes

Primary Outcome Measures

Percentage of Progression Free Survival
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.

Secondary Outcome Measures

Antitumor Activity
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.
Overall Survival
Overall survival is defined as the period from the date of first dose of TAS-109 to death date.

Full Information

First Posted
January 14, 2009
Last Updated
April 20, 2012
Sponsor
Taiho Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00824161
Brief Title
Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
Official Title
A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
TAS-109
Intervention Type
Drug
Intervention Name(s)
TAS-109
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Progression Free Survival
Description
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.
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.
Secondary Outcome Measure Information:
Title
Antitumor Activity
Description
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.
Time Frame
From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.
Title
Overall Survival
Description
Overall survival is defined as the period from the date of first dose of TAS-109 to death date.
Time Frame
From the initial treatment until 12 months after enrollment of the last patient.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Xiong, M.D., Ph.D.
Organizational Affiliation
The Center for Cancer and Blood Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Cancer Institute
City
East 34th Street, New York
State/Province
New York
ZIP/Postal Code
NY 10016
Country
United States
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Holcombe Boulevard, Houston
State/Province
Texas
ZIP/Postal Code
TX 77030
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
West Magnolia Avenue, Fort Worth
State/Province
Texas
ZIP/Postal Code
TX 76104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs