Trial record 1 of 1 for:
TAS-102 107
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment
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| ClinicalTrials.gov Identifier: NCT02301117 |
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Recruitment Status :
Recruiting
First Posted : November 25, 2014
Last Update Posted : September 18, 2018
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Sponsor:
Taiho Oncology, Inc.
Information provided by (Responsible Party):
Taiho Oncology, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumors | Drug: TAS-102 | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | January 2015 |
| Estimated Primary Completion Date : | July 2019 |
| Estimated Study Completion Date : | July 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: TAS-102 |
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Experimental: 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.
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Drug: TAS-102 |
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Experimental: 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 |
Drug: TAS-102 |
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Experimental: 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.
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Drug: TAS-102 |
Primary Outcome Measures :
- PK parameters of FTD, FTY, and TPI in plasma after a single dose of TAS-102 [ Time Frame: 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 ]FTD, FTY and TPI: pharmacokinetic parameters Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. FTD, FTY, and TPI: Ae% and CLr. FTD and TPI: CL/F, Vd/F of TAS-102
- Safety monitoring including adverse events, vital signs, and laboratory assessments [ Time Frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion
- Has provided written informed consent
- Has advanced solid tumors (excluding breast cancer)
- Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis
- ECOG performance status of ≤2
- Is able to take medications orally
- Has adequate organ function
- 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
- Certain serious illnesses or medical condition(s)
- 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
- Has received TAS-102
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Is a pregnant or lactating female
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301117
Contacts
| Contact: Robert Winkler, MD | 609-750-5300 | rwinkler@taihooncology.com | |
| Contact: Taiho Oncology, Inc | 855-598-8259 |
Locations
| United States, Arizona | |
| Phoenix Clinical Site | Completed |
| Phoenix, Arizona, United States, 85054 | |
| United States, California | |
| Duarte Clinical Site | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
| Santa Monica Clinical Site | Recruiting |
| Santa Monica, California, United States, 90095 | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
| United States, Florida | |
| Gainesville Clinical Site | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
| United States, Maryland | |
| Baltimore Clinical Site | Active, not recruiting |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Boston Clinical Site | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
| United States, Ohio | |
| Cleveland Clinical Site | Completed |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinical Site | Completed |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Pittsburgh Clinical Site | Completed |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| Dallas Clinical Site | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
| Czechia | |
| Brno Clinical Site | Recruiting |
| Brno, Czechia | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
| Praha Clinical Site | Recruiting |
| Praha, Czechia | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
| Serbia | |
| Belgrade Clinical Site | Recruiting |
| Belgrade, Serbia, 11080 | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
| Sremska Kamenica Clinical Site | Recruiting |
| Sremska Kamenica, Serbia, 21204 | |
| Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com | |
Sponsors and Collaborators
Taiho Oncology, Inc.
| Responsible Party: | Taiho Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT02301117 History of Changes |
| Other Study ID Numbers: |
TO-TAS-102-107 |
| First Posted: | November 25, 2014 Key Record Dates |
| Last Update Posted: | September 18, 2018 |
| Last Verified: | September 2018 |
Keywords provided by Taiho Oncology, Inc.:
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Renal Kidney Diseases Urologic Diseases Renal Insufficiency Renal Impairment Pharmacokinetics Advance Solid Tumor |
Creatinine Clearance Kidney Neoplasms Renal Tumor Kidney Urology Pharmacologic Action |
Additional relevant MeSH terms:
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Renal Insufficiency Kidney Diseases Urologic Diseases Trifluridine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |