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Trial record 33 of 59 for:    TAS-102

Study of TAS-102 in Patients With Metastatic Colorectal Cancer in Asia (TERRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01955837
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Brief Summary:
To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: TAS-102 Drug: Placebo Phase 3

Detailed Description:
This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Phase III Study of TAS-102 Versus Placebo in Asian Patients With Metastatic Colorectal Cancer Refractory or Intolerable to Standard Chemotherapies
Study Start Date : September 2013
Actual Primary Completion Date : February 16, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAS-102 Drug: TAS-102
TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.

Placebo Comparator: Placebo Drug: Placebo
Placebo orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Every 8 weeks. Survival status should be collected for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met, whichever is later. ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Every 8 weeks. Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met. ]

Other Outcome Measures:
  1. Safety and tolerability evaluation will focus on adverse events and laboratory assessments. [ Time Frame: Until 30 day safety follow-up visit or until initiation of new anticancer treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has provided written informed consent
  • Has adenocarcinoma of the colon or rectum
  • Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
  • ECOG performance status of 0 or 1
  • Is able to take medication orally
  • Has adequate organ function (bone marrow, kidney and liver)
  • Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955837


Locations
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China
Peking University Cancer Hospital
Beijing, China, 100142
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Thailand
Chulalongkorn University & The King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01955837     History of Changes
Other Study ID Numbers: 10040090
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases