A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment
NCT ID: NCT02301117
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2015-01-31
2019-06-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment
NCT02301104
Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors
NCT01867879
An Investigation of TAS-119 Monotherapy
NCT02448589
A Study of TAS-116 in Patients With Solid Tumors
NCT02965885
Study of ASTX029 in Subjects With Advanced Solid Tumors
NCT03520075
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mild Renal Impairment
35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
TAS-102
Moderate Renal Impairment
35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
TAS-102
Severe Renal Impairment
35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
The dose level of severe cohort will be determined based on the Interim Assessment of mild and moderate cohorts
TAS-102
Normal Renal Function
35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
TAS-102
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAS-102
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Has advanced solid tumors (excluding breast cancer)
3. Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis
4. ECOG performance status of ≤2
5. Is able to take medications orally
6. Has adequate organ function
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taiho Oncology, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix Clinical Site
Phoenix, Arizona, United States
Duarte Clinical Site
Duarte, California, United States
Santa Monica Clinical Site
Santa Monica, California, United States
Gainesville Clinical Site
Gainesville, Florida, United States
Baltimore Clinical Site
Baltimore, Maryland, United States
Boston Clinical Site
Boston, Massachusetts, United States
Cleveland Clinical Site
Cleveland, Ohio, United States
Cleveland Clinical Site
Cleveland, Ohio, United States
Pittsburgh Clinical Site
Pittsburgh, Pennsylvania, United States
Dallas Clinical Site
Dallas, Texas, United States
Brno Clinical Site
Brno, , Czechia
Praha Clinical Site
Prague, , Czechia
Belgrade Clinical Site
Belgrade, , Serbia
Sremska Kamenica Clinical Site
Kamenitz, , Serbia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Saif MW, Becerra CR, Fakih MG, Sun W, Popovic L, Krishnamurthi S, George TJ, Rudek MA, Shepard DR, Skopek J, Sramek V, Zaric B, Yamamiya I, Benhadji KA, Hamada K, He Y, Rosen L. A phase I, open-label study evaluating the safety and pharmacokinetics of trifluridine/tipiracil in patients with advanced solid tumors and varying degrees of renal impairment. Cancer Chemother Pharmacol. 2021 Sep;88(3):485-497. doi: 10.1007/s00280-021-04308-z. Epub 2021 Jun 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TO-TAS-102-107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.