A Study of TAS-116 in Patients With Solid Tumors

NCT02965885 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: TAS-116-101100580102015-005328-24
• Study Type: interventional
• Target: 31
• Locations: 3 countries
• Sites: 12

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

Phase I; Solid Tumors; Pharmacokinetics; Pharmacodynamics; MTD; TAS116; HSP90 Inhibitor; Neoplasms; HER2 positive MBC; NSCLC EGFR; NSCLC ALK positive

Outcome Measures

Primary Outcomes (3)

• Number of patients experiencing Dose Limiting Toxicity graded according to CTCAE Version 4.03, observed in the Cycle 1 in order to meet the objective of assessment of the MTD of TAS-116 (Part A)

  21 days in Cycle 1

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Parts A, B and C)

  Safety monitoring will begin at the informed consent obtained and continue up to 28 days after the last dose of TAS-116 or until new anti-tumor therapy, whichever is earlier.

• Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Part C)

  Up to 2 Years

Secondary Outcomes (6)

• Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B)

  21 days in Cycle 1

• Area under the plasma drug concentration-time curve (AUC) after administration of TAS-116 (Parts A and B)

  21 days in Cycle 1

• Disease Control Rate using RECIST 1.1 (Parts A, B, and C)

  Up to last participant completes at least 6 months

• Duration of Response (Part C)

  Up to last participant completes at least 6 months

• Progression Free Survival (Part C)

  Up to last participant completes at least 6 months

Study Arms (1)

TAS-116

EXPERIMENTAL

Drug: TAS-116

Interventions

TAS-116 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.

TAS-116

Eligibility Criteria

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

You may qualify if:

• Male or females with an age ≥ 18 years (≥ 20 years in Japan)
• 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
• Has At least one measurable lesion as defined by RECIST criteria
• Is able to take medications orally (e.g., no feeding tube).
• Is able to agree to and sign informed consent and to comply with the protocol
• Has adequate organ function

You may not qualify if:

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

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (12)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Greenville Health System, Institute for Translational Oncology Research

Greenville, South Carolina, 29605, United States

Location

US Oncology - Virginia Cancer Specialists, P.C.

Fairfax, Virginia, 86885, United States

Location

Policlinico S.Orsola-Malpighi, U.O. Oncologia Medica

Bologna, 40138, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele Oncologia Medica

Catania, 95123, Italy

Location

Istituto Europeo di Oncologia , Sviluppo di Nuovi Farmaci per Terapie Innovative

Milan, 20141, Italy

Location

Regina Elena National Cancer Institute

Roma, 00144, Italy

Location

Northern Centre for Cancer Care

Newcastle upon Tyne, England, United Kingdom

Location

Division of Cancer Studies, Kings College London

London, SE19 9RT, United Kingdom

Location

Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

Location

The Christie NHS Foundation Trust Institute of Cancer Sciences, University of Manchester

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden

Sutton, SM2 5PTT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

TAS-116

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 17, 2016
• Study Start: July 10, 2017
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: September 4, 2024

Record last verified: 2024-08

Locations

IT (4); GB (5); US (3)