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Trial record 20 of 59 for:    TAS-102

Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT01867879
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Brief Summary:
The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors (Excluding Breast Cancer) Drug: TAS-102 Drug: Placebo Phase 1

Detailed Description:
This is a Phase 1, nonrandomized study to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors. The study is conducted in 2 phases: the cardiac safety evaluation phase to investigate cardiac repolarization and the cardiac safety profile (Cycle 1) and the extension phase to assess the safety profile and antitumor activity (subsequent cycles).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 in Patients With Advanced Solid Tumors
Study Start Date : June 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAS-102 Drug: TAS-102
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.

Placebo Comparator: Placebo Drug: Placebo
Placebo tablets, orally, single dose.




Primary Outcome Measures :
  1. QTc interval [ Time Frame: Days -2, -1, 1, and 12 of Cycle 1 ]
    Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1)


Secondary Outcome Measures :
  1. Quantitative and Qualitative ECG parameters [ Time Frame: Days -2, -1, 1, and 12 of Cycle 1 ]
    Predose (Day -2) to postdose changes and absolute values in quantitative Holter ECG parameters (heart rate, RR, PR and QRS intervals) after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1). In addition, qualitative assessments of Holter ECG recordings will be performed.

  2. Relationship between TAS-102 pharmacokinetics and its effect on cardiac repolarization [ Time Frame: Days 1 and 12 of Cycle 1 ]
    Pharmacokinetic samples are taken on Days 1 and 12 of Cycle 1. The relationship between plasma concentrations of TAS-102 and the change from baseline in QTc adjusted by placebo will be quantified using a linear mixed effect model approach.

  3. 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 ]
    Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.

  4. Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 8 weeks through Cycle 6 (ie, through 24 weeks). Thereafter, assessments will be performed at least every 12 weeks according to site standard of care, until at least one of the treatment discontinuation criteria is met. ]


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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 Criteria:

  1. Has provided written informed consent
  2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
  3. Has received no more than 5 prior cancer therapies
  4. ECOG performance status of 0 or 1
  5. Is able to take medications orally
  6. Corrected QT interval using Bazett's correction is no more than 450 msec on resting ECG
  7. Has adequate organ function (bone marrow, kidney and liver)
  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. Has had certain other recent treatment e.g. major surgery, extended field radiation, 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 a family history of unexplained sudden death or long QT syndrome
  4. Has had a documented cardiovascular complication following a fluoropyrimidine-derived treatment
  5. Is a patient for whom it is not technically possible to obtain quality ECG tracings
  6. Is receiving a concomitant drug that is known to affect QT interval or to be arrhythmogenic
  7. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
  8. Known sensitivity to TAS-102 or its components
  9. Is a pregnant or lactating female
  10. Refuses to use an adequate means of contraception (including male patients)

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): NCT01867879


Locations
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United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
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Principal Investigator: Johanna Bendell, MD SCRI Development Innovations, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01867879     History of Changes
Other Study ID Numbers: TPU-TAS-102-103
2013-000650-21 ( EudraCT Number )
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015
Keywords provided by Taiho Oncology, Inc.:
Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
Additional relevant MeSH terms:
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Neoplasms