Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01607957 · ClinicalTrials.gov registry record · Phase 3
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
A Phase 3 study, sponsored by Taiho Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
NCT01607957: Completed Phase 3 study, sponsored by Taiho Oncology.
NCT01607957 is a Phase 3 study that has completed, run by Taiho Oncology. The registered enrollment target is 800 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01607957, a Phase 3 study, has completed, sponsored by Taiho Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG TAS-102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2012-06-17 |
| Est. Completion | 2016-05-23 |
| Phase | Phase 3 |
What the finished NCT01607957 record still lists
NCT01607957 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01607957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01607957 about?
NCT01607957 is a clinical study titled "Study of TAS-102 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.
What is the current status of trial NCT01607957?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2012-06-17. Estimated completion is 2016-05-23.
What interventions are being tested in trial NCT01607957?
The interventions under investigation include: Placebo (DRUG), TAS-102 (DRUG).
Who is sponsoring clinical trial NCT01607957?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01607957's enrollment target sits among peer trials
800 414th of 2000 higher than 1,573 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00695214 · 800 participants · Phase 2
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
- NCT03048201 · 800 participants · NA
Physica System Total Knee Replacement Registry Study
- NCT03792659 · 800 participants
The EXPLORE MG Registry for Myasthenia Gravis
- NCT03819296 · 800 participants · Phase 1
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI