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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01607957
First received: May 24, 2012
Last updated: December 13, 2013
Last verified: December 2013

May 24, 2012
December 13, 2013
June 2012
June 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01607957 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ 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. ] [ Designated as safety issue: No ]
  • Safety and tolerability evaluation will focus on adverse events and laboratory assessments [ Time Frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Every 8 weeks. Tumor assessments will be performed until the patient develops radiologic progression or until the start of new anticancer treatment, for up to 12 months after the last patient is randomized. ] [ Designated as safety issue: No ]
  • Safety and tolerability evaluation will focus on adverse events and laboratory assessments [ Time Frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
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

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

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: 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.
  • Drug: 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.
  • Experimental: TAS-102
    Intervention: Drug: TAS-102
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
December 2014
June 2014   (final data collection date for primary outcome measure)

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.

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Czech Republic,   France,   Germany,   Ireland,   Italy,   Japan,   Spain,   Sweden,   United Kingdom
 
NCT01607957
TPU-TAS-102-301, 2012-000109-66
Yes
Taiho Oncology, Inc.
Taiho Oncology, Inc.
Not Provided
Principal Investigator: Robert J Mayer, MD Dana-Farber Cancer Institute
Principal Investigator: Eric Van Cutsem, MD University Hospital, Gasthuisberg
Principal Investigator: Atsushi Ohtsu, MD National Cancer Center Hospital East
Taiho Oncology, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP