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

Taiho Pharma

Status and phase: Terminated; Phase 2

Conditions: Advanced Colorectal Cancer

Treatments: Drug: TAS-109

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824161

TAS109-0403

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

1

Experimental group

Description:

TAS-109

Treatment:

Drug: TAS-109