Clinical trial · Interventional
Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors
A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 in Patients With Advanced Solid Tumors
NCT01867879CI-TRIAL-00080475completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors (Excluding Breast Cancer) | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| TAS-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAS-102
- interventionNames
- Drug: TAS-102
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- QTc interval
- timeFrame
- Days -2, -1, 1, and 12 of Cycle 1
- description
- Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has provided written informed consent 2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists 3. Has received no more than 5 prior cancer therapies 4. ECOG performance status of 0 or 1 5. Is able to take medications orally 6. Corrected QT interval using Bazett's correction is no more than 450 msec on resting ECG 7. Has adequate organ function (bone marrow, kidney and liver) 8. 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. Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 2. Certain serious illnesses or medical condition(s) 3. Has a family history of unexplained sudden death or long QT syndrome 4. Has had a documented cardiovascular complication following a fluoropyrimidine-derived treatment 5. Is a patient for whom it is not technically possible to obtain quality ECG tracings 6. Is receiving a concomitant drug that is known to affect QT interval or to be arrhythmogenic 7. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies 8. Known sensitivity to TAS-102 or its components 9. Is a pregnant or lactating female 10. Refuses to use an adequate means of contraception (including male patients)
References
Publications (1)
- DERIVEDBendell JC, Patel MR, Yoshida K, Seraj J, Weaver R, Lemech C, Todaro TG, Pant S, Arkenau HT. Phase 1 study of cardiac safety of TAS-102 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Jun;77(6):1275-83. doi: 10.1007/s00280-016-3031-9. Epub 2016 May 5. PMID 27151157