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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01607957




Registration number
NCT01607957
Ethics application status
Date submitted
24/05/2012
Date registered
30/05/2012
Date last updated
4/06/2020

Titles & IDs
Public title
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
Scientific title
Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
Secondary ID [1] 0 0
2012-000109-66
Secondary ID [2] 0 0
TPU-TAS-102-301
Universal Trial Number (UTN)
Trial acronym
RECOURSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAS-102
Treatment: Drugs - Placebo

Experimental: TAS-102 -

Placebo Comparator: Placebo -


Treatment: Drugs: 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 are met.

Treatment: Drugs: Placebo
Placebo tablets, 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 are met.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy.
Timepoint [1] 0 0
Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)
Secondary outcome [1] 0 0
Progression-free Survival - Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated.
Timepoint [1] 0 0
Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014)
Secondary outcome [2] 0 0
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths - An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.
Timepoint [2] 0 0
From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier

Eligibility
Key inclusion criteria
1. Has provided written informed consent

2. Has adenocarcinoma of the colon or rectum

3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic
colorectal cancer

4. ECOG performance status of 0 or 1

5. Is able to take medications orally

6. Has adequate organ function (bone marrow, kidney and liver)

7. 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Certain serious illnesses or medical condition(s)

2. 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

3. Has received TAS-102

4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any
prior therapies

5. Is a pregnant or lactating female

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [2] 0 0
The Queen Elisabeth Hospital - Woodville South
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Perth
Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Florida
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Illinois
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Indiana
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Louisiana
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Massachusetts
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Michigan
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Missouri
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New Hampshire
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Ohio
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Virginia
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Austria
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Linz
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Austria
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Wels
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Wien
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Brussels
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Belgium
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Charleroi
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Edegem
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Gent
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Leuven
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Hradec Kralove
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Czechia
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Nova Ves pod Plesi
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Besancon
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Bordeaux
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Lille
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Paris cedex 12
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Rennes cedex
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Berlin
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Bonn
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Dresden
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Germany
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Frankfurt
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Halle (Saale)
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Hamburg
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Koeln
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Mainz
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Mannheim
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Muenchen
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München
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Ulm
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Napoli
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Pisa
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Reggio Emilia
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Rimini
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Sondrio
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Aichi
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Chiba
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Hokkaido
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Hyogo
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Ibaraki
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Kanagawa
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Osaka
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Saitama
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Shizuoka
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Tochigi
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Tokyo
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Fukuoka
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Kumamoto
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Tokushima
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Barcelona
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Lleida
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Madrid
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Malaga
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Murcia
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Sabadell
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Sevilla
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Valencia
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Sweden
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Stockholm
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Sweden
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Uppsala
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United Kingdom
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Aberdeen
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Bristol
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Leeds
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London
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United Kingdom
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Taiho Oncology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01607957
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
From - Boston, MA
Address 0 0
Dana-Farber Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications