Clinical trial NCT01867879: Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors
Official title: A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors (Excluding Breast Cancer)
Keywords: Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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).

Eligibility 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)

Primary outcomes:
measure: QTc interval
timeFrame: Days -2, -1, 1, and 12 of Cycle 1
Secondary outcomes:
measure: Quantitative and Qualitative ECG parameters
timeFrame: Days -2, -1, 1, and 12 of Cycle 1
measure: Relationship between TAS-102 pharmacokinetics and its effect on cardiac repolarization
timeFrame: Days 1 and 12 of Cycle 1
measure: Safety monitoring including adverse events, vital signs, and laboratory assessments
timeFrame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
measure: Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Johanna Bendell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.