Clinical Trials /

A Study of TAS-116 in Patients With Solid Tumors

NCT02965885

Description:

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 Conditions:
  • Breast Carcinoma
  • Gastric Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of TAS-116 in Patients With Solid Tumors
  • Official Title: A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: TAS-116-101
  • SECONDARY ID: 10058010
  • SECONDARY ID: 2015-005328-24
  • NCT ID: NCT02965885

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
TAS-116TAS-116

Purpose

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 enrol 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 harbouring EGFR mutations (EGFRT790M+) or EGFR mutations (T790M-) 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.

Trial Arms

NameTypeDescriptionInterventions
TAS-116Experimental
  • TAS-116

Eligibility Criteria

        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, EGFR T790M positive Advanced
             NSCLC, EGFR T790M negative

          3. At least one measurable lesion for solid tumors.

          4. Is able to take medications orally (e.g., no feeding tube).

          5. 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 proscribed treatments within specified time frames
             prior to study drug administration

          3. Significant ophthalmologic abnormality,

          4. Impaired cardiac function or clinically significant cardiac disease
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B)
Time Frame:21 days in Cycle 1
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Disease Control Rate using RECIST 1.1 (Parts A, B, and C)
Time Frame:Up to 2 Years
Safety Issue:
Description:
Measure:Duration of Response (Part C)
Time Frame:Up to 2 Years
Safety Issue:
Description:
Measure:Progression Free Survival (Part C)
Time Frame:Up to 2 Years
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Up to last participant completes at least 6 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Taiho Oncology, Inc.

Trial Keywords

  • Phase I
  • Solid Tumors
  • Pharmacokinetics
  • Pharmacodynamics
  • MTD
  • TAS116
  • HSP90 Inhibitor
  • Neoplasms
  • HER2 positive MBC
  • NSCLC EGFR T790M Positive
  • NSCLC EGFR T790M Negative

Last Updated

August 15, 2017