A Study of TAS-116 in Patients With Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965885
• Other study ID #: TAS-116-101
• Secondary ID: 100580102015-005
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2017
• Est. completion date: May 3, 2019

Study information

• Verified date: May 2019
• Source: Taiho Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi, U.O. Oncologia Medica	Bologna
Italy	Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele Oncologia Medica	Catania
Italy	Istituto Europeo di Oncologia , Sviluppo di Nuovi Farmaci per Terapie Innovative	Milano
Italy	Regina Elena National Cancer Institute	Roma
United Kingdom	Division of Cancer Studies, Kings College London	London
United Kingdom	Sarah Cannon Research Institute UK	London
United Kingdom	The Christie NHS Foundation Trust Institute of Cancer Sciences, University of Manchester	Manchester
United Kingdom	Northern Centre for Cancer Care	Newcastle Upon Tyne	England
United Kingdom	Royal Marsden	Sutton
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	US Oncology - Virginia Cancer Specialists, P.C.	Fairfax	Virginia
United States	Greenville Health System, Institute for Translational Oncology Research	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Countries where clinical trial is conducted

United States,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Part C)		Up to 2 Years
Secondary	Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B)		21 days in Cycle 1
Secondary	Area under the plasma drug concentration-time curve (AUC) after administration of TAS-116 (Parts A and B)		21 days in Cycle 1
Secondary	Disease Control Rate using RECIST 1.1 (Parts A, B, and C)		Up to last participant completes at least 6 months
Secondary	Duration of Response (Part C)		Up to last participant completes at least 6 months
Secondary	Progression Free Survival (Part C)		Up to last participant completes at least 6 months
Secondary	Overall Survival		Up to last participant completes at least 6 months