Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

TAS-109

Henry Xiong, M.D., Ph.D.

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

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

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

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.

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 is defined as the period from the date of first dose of TAS-109 to death date.

Taiho Pharmaceutical Co., Ltd.

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Scott Kopetz, MD

TAS-109 2.0 mg/m\^2/day Independent Assessment

Analysis was Intent to treatment(ITT) population.

Percentage of Progression Free Survival

Antitumor Activity

Analysis was Intent to Treat(ITT) population.

Spots Global Cancer Trial Database for Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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