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A Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors

NCT02025803 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-05

No results posted yet for this study

Summary

The purpose of this exploratory study is to investigate the safety and determine the maximum tolerated dose (MTD) of TAS-114 in combination with capecitabine in patients with advanced solid tumors for which the patients have no available therapy likely to convey clinical benefit.

Conditions

  • Neoplasms

Interventions

DRUG

TAS-114/capecitabine

Part 1 (dose-escalation phase): Treatment cycles of TAS-114 and capecitabine orally BID for 14 days followed by 7 days rest until at least one of the discontinuation criteria are met TAS-114 dose starting at 20mg/m2/day with capecitabine dose of 760 mg/m2/day. TAS-114 doses will be escalated for each cohort up to 480mg/m2/day. If MTD is not reached by TAS-114 dose of 480mg/m2/day, the capecitabine dose will be escalated Part 2 (expansion phase): TAS-114 and capecitabine MTD established in Part 1 administered BID for 14 days followed by 7-day recovery period (21-day cycle).

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-07-07
Completion
2017-07-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025803 on ClinicalTrials.gov