Study of TAS-102 in Patients With Metastatic Colorectal Cancer in Asia
This trial is active, not recruiting.
|Sponsor||Taiho Pharmaceutical Co., Ltd.|
|Start date||September 2013|
|End date||February 2016|
|Trial size||400 participants|
|Trial identifier||NCT01955837, 10040090|
To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Beijing, China||Peking University Cancer Hospital||no longer recruiting|
|Shanghai, China||Fudan University Shanghai Cancer Center||no longer recruiting|
|Songpa-gu, Korea, Republic of||Asan Medical Center||no longer recruiting|
|Bangkok, Thailand||Chulalongkorn University & The King Chulalongkorn Memorial Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
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.
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.
Male or female participants at least 18 years old.
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.
|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|
|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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