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

NCT01867879 | Completed Phase 1

• 2 other identifiers: TPU-TAS-102-1032013-000650-21
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumors (Excluding Breast Cancer)

Keywords

Advanced solid tumors (excluding breast cancer) for which no standard therapy exists

Outcome Measures

Primary Outcomes (1)

• QTc interval

  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)

  Days -2, -1, 1, and 12 of Cycle 1

Secondary Outcomes (4)

• Quantitative and Qualitative ECG parameters

  Days -2, -1, 1, and 12 of Cycle 1

• Relationship between TAS-102 pharmacokinetics and its effect on cardiac repolarization

  Days 1 and 12 of Cycle 1

• Safety monitoring including adverse events, vital signs, and laboratory assessments

  Through 30 days following last administration of study medication or until initiation of new anticancer treatment

• Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)

  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.

Study Arms (2)

TAS-102

EXPERIMENTAL

Drug: TAS-102

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAS-102 DRUG

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.

TAS-102

Placebo DRUG

Placebo tablets, orally, single dose.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided written informed consent
• Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
• Has received no more than 5 prior cancer therapies
• ECOG performance status of 0 or 1
• Is able to take medications orally
• Corrected QT interval using Bazett's correction is no more than 450 msec on resting ECG
• Has adequate organ function (bone marrow, kidney and liver)
• 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.

You may not qualify if:

• 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
• Certain serious illnesses or medical condition(s)
• Has a family history of unexplained sudden death or long QT syndrome
• Has had a documented cardiovascular complication following a fluoropyrimidine-derived treatment
• Is a patient for whom it is not technically possible to obtain quality ECG tracings
• Is receiving a concomitant drug that is known to affect QT interval or to be arrhythmogenic
• Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
• Known sensitivity to TAS-102 or its components
• Is a pregnant or lactating female
• Refuses to use an adequate means of contraception (including male patients)

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (1)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Bendell JC, Patel MR, Yoshida K, Seraj J, Weaver R, Lemech C, Todaro TG, Pant S, Arkenau HT. Phase 1 study of cardiac safety of TAS-102 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Jun;77(6):1275-83. doi: 10.1007/s00280-016-3031-9. Epub 2016 May 5.

  PMID: 27151157 DERIVED

MeSH Terms

Interventions

trifluridine tipiracil drug combination

Study Officials

• Johanna Bendell, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 4, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: April 1, 2015
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

US (1)