Trial record 2 of 8 for:    tas-102

Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Taiho Oncology, Inc.
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT02031055
First received: December 18, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD or [14C]TPI.


Condition Intervention Phase
Advanced Solid Tumors
Drug: TAS-102 with a light tracer dose of [14C]FTD
Drug: TAS-102 with a light tracer dose of [14C] TPI
Drug: TAS-102 tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label Study to Evaluate the Mass Balance of Orally Administered FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Taiho Oncology, Inc.:

Primary Outcome Measures:
  • Urinary, fecal, and respiratory excretion of 14C from FTD and urinary and fecal excretion of 14C from TPI [ Time Frame: Day 1 through day 8 (through 168 hours postdose) ] [ Designated as safety issue: No ]
    Urine and feces samples will be collected at 24-hour intervals through 168 hours postdose. For [14C]FTD only, samples of CO2 will be trapped from expired air immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose.

  • PK parameters of total radioactivity (AUC0-inf, AUC0-last, Cmax, Tmax, and T1/2) in whole blood and plasma after a single dose of TAS-102 [ Time Frame: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose ] [ Designated as safety issue: No ]
  • Metabolic profile of FTD and TPI in plasma, urine, and feces [ Time Frame: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose. Urine and feces samples will be collected at 24-hour intervals through 168 hours postdose. ] [ Designated as safety issue: No ]
    Characterization of FTD and TPI metabolites

  • PK parameters of FTD, FTY, and TPI in plasma (Cmax, Tmax, AUC0-last, AUC0-inf, T1/2, CL/F, and Vd/F) [ Time Frame: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose. ] [ Designated as safety issue: No ]
    Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2 will be calculated for each analyte, and CL/F and Vd/F will be calculated for FTD and TPI


Secondary Outcome Measures:
  • 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, whichever comes first ] [ Designated as safety issue: Yes ]
    Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used

  • Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 8 weeks during the extension phase through Cycle 6 (through 24 weeks) and at least every 12 weeks thereafter, until treatment discontinuation (ie, due to disease progression, AEs, patient death, physician decision, pregnancy, or patient request) ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAS-102 with light tracer dose of [14C]FTD Drug: TAS-102 with a light tracer dose of [14C]FTD
A single dose of 60 mg TAS-102 with a light tracer dose (200 nCi, approximately 1.2 μg) of [14C]FTD administered as an oral solution on Day 1 (mass balance part)
Other Name: Oral Solution
Drug: TAS-102 tablets
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. Treatment starts during study extension part (day 9 of the study).
Experimental: TAS-102 with light tracer dose of [14C]TPI Drug: TAS-102 with a light tracer dose of [14C] TPI
A single dose of 60 mg TAS-102 with a light tracer dose (1000 nCi, approximately 5.6 μg) of [14C]TPI administered as an oral solution on Day 1 (mass balance part)
Other Name: Oral solution
Drug: TAS-102 tablets
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. Treatment starts during study extension part (day 9 of the study).

Detailed Description:

This is a Phase 1, open-label study evaluating the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD or [14C]TPI. The study will be conducted in 2 parts: mass balance part and TAS-102 extension part. After completion of the mass balance part, patients will receive continued treatment with TAS-102 during the study extension part.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has advanced solid tumors (excluding previously treated breast cancer) for which no standard therapy exists
  2. ECOG performance status of 0 or 1
  3. Is able to take medications orally
  4. Has adequate organ function (bone marrow, kidney and liver)
  5. 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. 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 had either partial or total gastrectomy
  4. Has a medical condition that jeopardizes or impairs ability to collect representative excreta
  5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
  6. Known sensitivity to TAS-102 or its components
  7. Is a pregnant or lactating female
  8. Refuses to use an adequate means of contraception (including male patients)
  9. Is an occupationally exposed worker as defined by relevant ionizing radiation regulations
  10. Has been exposed to 14C in the last 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031055

Contacts
Contact: Jabed Seraj, MD, PhD. seraj@taihopui.com

Locations
United States, Pennsylvania
University of Pittsbutgh Cancer Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
Principal Investigator: Jan H Beumer, PharmD, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02031055     History of Changes
Other Study ID Numbers: TPU-TAS-102-108
Study First Received: December 18, 2013
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Taiho Oncology, Inc.:
Advanced solid tumors

Additional relevant MeSH terms:
Neoplasms
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014