A Study of TAS-116 in Patients With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2019-05-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are being evaluated. This phase I study is also planned to enroll patients with advanced solid tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of TAS-116 on the 5 days on/2 days off regimen.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of TAS-114 in Combination With S-1

NCT02454062

Advanced Solid Tumors

COMPLETED PHASE1

A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment

NCT02301117

Advanced Solid Tumors

COMPLETED PHASE1

A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment

NCT02301104

Advanced Solid Tumors

COMPLETED PHASE1

An Investigation of TAS-119 Monotherapy

NCT02448589

Advanced Solid Tumors

TERMINATED PHASE1

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

NCT02025803

Neoplasms

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAS-116

Group Type EXPERIMENTAL

TAS-116

Intervention Type DRUG

TAS-116 is an oral heat shock protein 90 (HSP90) inhibitor investigated in 3 dosing regimens (QD, QOD, 5 days on 2 days off) in patients with advanced solid tumor and then at one dose schedule in advanced breast and lung cancer.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAS-116

TAS-116 is an oral heat shock protein 90 (HSP90) inhibitor investigated in 3 dosing regimens (QD, QOD, 5 days on 2 days off) in patients with advanced solid tumor and then at one dose schedule in advanced breast and lung cancer.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or females with an age ≥ 18 years (≥ 20 years in Japan)
2. Patients with histological- or cytological-confirmed, advanced unresectable breast, gastric, or non-small cell lung cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.

a. Part C: Only the following subtype of tumors with the molecular/genetic alterations will be enrolled: HER2 positive MBC Advanced NSCLC, harboring EGFR mutations after progression on osimertinib Advanced NSCLC, harboring ALK translocations after treatment with alectinib or at least 2 ALK inhibitors
3. Has At least one measurable lesion as defined by RECIST criteria
4. Is able to take medications orally (e.g., no feeding tube).
5. Is able to agree to and sign informed consent and to comply with the protocol
6. Has adequate organ function

Exclusion Criteria

1. Has a serious illness or medical condition(s)
2. Has received treatment with any prescribed treatments within specified time frames prior to study drug administration
3. Significant ophthalmologic abnormality,
4. Impaired cardiac function or clinically significant cardiac disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No