Clinical trial NCT02301117: A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment
Official title: A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAS-102 in Patients With Advanced Solid Tumors and Varying Degrees of Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Renal
Kidney Diseases
Urologic Diseases
Renal Insufficiency
Renal Impairment
Pharmacokinetics
Advance Solid Tumor
Creatinine Clearance
Kidney Neoplasms
Renal Tumor
Kidney
Urology
Pharmacologic Action
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.

Detailed description: This is a Phase 1, open-label study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors with varying degrees of renal impairment. The study is conducted in 2 parts: the Pharmacokinetic Part (Cycle 1) and the Extension Part (Cycles 2 and beyond). Patients may continue to receive treatment with TAS-102 during the study extension part only after completion of the Pharmacokinetic Part.

Eligibility criteria: Inclusion

1. Has provided written informed consent
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

Primary outcomes:
measure: PK parameters of FTD, FTY, and TPI in plasma after a single dose of TAS-102
timeFrame: Blood samples will be collected in Cycle 1 Day 1 and Day 12 at pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours post AM dose of TAS-102
measure: Safety monitoring including adverse events, vital signs, and laboratory assessments
timeFrame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Clinical Site
state: Arizona
city: Duarte
country: United States
facility: Duarte Clinical Site
state: California
city: Santa Monica
country: United States
facility: Santa Monica Clinical Site
state: California
city: Gainesville
country: United States
facility: Gainesville Clinical Site
state: Florida
city: Baltimore
country: United States
facility: Baltimore Clinical Site
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Site
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinical Site
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinical Site
state: Ohio
city: Pittsburgh
country: United States
facility: Pittsburgh Clinical Site
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Clinical Site
state: Texas
city: Brno
country: Czechia
facility: Brno Clinical Site
city: Praha
country: Czechia
facility: Praha Clinical Site
city: Belgrade
country: Serbia
facility: Belgrade Clinical Site
city: Sremska Kamenica
country: Serbia
facility: Sremska Kamenica Clinical Site
Study officials:
References:
citation: 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.