Phase 3 N=800 Randomized Quadruple-blind Treatment

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01607957 ↗

Enrolled (actual)

800

Serious AEs

31.0%

Results posted

May 2019

Primary outcome: Primary: Overall Survival — 7.1; 5.3 months — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TAS-102 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Taiho Oncology, Inc.
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	7.1; 5.3	<0.0001 sig
SECONDARY Progression-free Survival	2.0; 1.7	<0.0001 sig
SECONDARY Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	98.3; 93.2; 85.7; 54.7; 69.4; 51.7	—

Summary

The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

Eligibility 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 medications 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.

Exclusion Criteria

Certain serious illnesses or medical condition(s)
Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
Has received TAS-102
Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
Is a pregnant or lactating female

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01607957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.