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NCT Number: NCT02965885

A Study of TAS-116 in Patients With Solid Tumors

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.

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Key information

Conditions

Advanced Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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)

    Time frame: 21 days in Cycle 1

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

    Time frame: 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.

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

    Time frame: Up to 2 Years

Secondary outcomes

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

    Time frame: 21 days in Cycle 1

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

    Time frame: 21 days in Cycle 1

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

    Time frame: Up to last participant completes at least 6 months

  4. Duration of Response (Part C)

    Time frame: Up to last participant completes at least 6 months

  5. Progression Free Survival (Part C)

    Time frame: Up to last participant completes at least 6 months

  6. Overall Survival

    Time frame: Up to last participant completes at least 6 months

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study title

A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2016
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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