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

Advanced Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00824161
• Other study ID #: TAS109-0403
• Status: Terminated
• Phase: Phase 2
• First received: January 14, 2009
• Last updated: April 20, 2012
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Cancer Institute	East 34th Street, New York	New York
United States	The University of Texas M.D. Anderson Cancer Center	Holcombe Boulevard, Houston	Texas
United States	The Center for Cancer and Blood Disorders	West Magnolia Avenue, Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Secondary	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.	From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.	No
Secondary	Overall Survival	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.	No