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

NCT00824161 | Terminated Phase 2 Results DMC

• 1 other identifier: TAS109-0403
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Antitumor Activity

  From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.

• Overall Survival

  From the initial treatment until 12 months after enrollment of the last patient.

Study Arms (1)

1

EXPERIMENTAL

TAS-109

Drug: TAS-109

Interventions

TAS-109 DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (3)

NYU Cancer Institute

East 34th Street, New York, New York, NY 10016, United States

Location

The University of Texas M.D. Anderson Cancer Center

Holcombe Boulevard, Houston, Texas, TX 77030, United States

Location

The Center for Cancer and Blood Disorders

West Magnolia Avenue, Fort Worth, Texas, TX 76104, United States

Location

Results Point of Contact

• Title: Scott Kopetz, MD
• Organization: The University of Texas M.D. Anderson Cancer Center

713-792-2828

Study Officials

• Henry Xiong, M.D., Ph.D.

  The Center for Cancer and Blood Disorders

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 23, 2012
• Results First Posted: August 17, 2011

Record last verified: 2012-04

Locations

US (3)