Protocol Summary

Protocol No.: OCR15033

Sponsor Protocol No.: TO-TAS-102-107

Study 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

Principal Investigator(s)
George, Thomas

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

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.

Phase: Phase I

Age Group: Adult

Scope: National

Treatment
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.

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.

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.

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.

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years old or older
2. Has provided written informed consent
3. Has advanced solid tumors (excluding breast cancer)
4. Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis
5. ECOG performance status of ≤2
6. Is able to take medications orally
7. Has adequate organ function
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. 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

Applicable Disease Sites

Colon Cancer

Participating Institutions
UF Gainesville : Twanda Robinson

Contact
Twanda Robinson, RN
Phone: +1 352-273-9489
Email: twanda.robinson@medicine.ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02301117