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A Study of TAS-116 in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02965885
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: TAS-116 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: TAS-116 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965885


Contacts
Contact: Elizabeth Calleja, MD +1-609-285-5280 ECalleja@taihooncology.com

Locations
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, South Carolina
Greenville Health System, Institute for Translational Oncology Research Recruiting
Greenville, South Carolina, United States, 29605
United States, Virginia
US Oncology - Virginia Cancer Specialists, P.C. Recruiting
Fairfax, Virginia, United States, 86885
Italy
Policlinico S.Orsola-Malpighi, U.O. Oncologia Medica Recruiting
Bologna, Italy, 40138
Contact: Stefania Salvagni    0039 0512142204    stefania.salvagni@aosp.bo.it   
Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele Oncologia Medica Recruiting
Catania, Italy, 95123
Contact: Soto Parra    0039 0953782426    hsotoparra@policlinico.unict.it   
Contact       hsotoparra@yahoo.it   
Istituto Europeo di Oncologia , Sviluppo di Nuovi Farmaci per Terapie Innovative Recruiting
Milano, Italy, 20141
Contact: Giuseppe Curigliano    0039 0257489439    giuseppe.curigliano@ieo.it   
Regina Elena National Cancer Institute Not yet recruiting
Roma, Italy, 00144
Contact: Francesco Cognetti    0039 0652666919    francesco.cognetti@ifo.gov.it   
United Kingdom
Northern Centre for Cancer Care Recruiting
Newcastle Upon Tyne, England, United Kingdom
Contact: Ruth Plummer    +44 (0) 191 208 4414    Ruth.Plummer@newcastle.ac.uk   
Division of Cancer Studies, Kings College London Recruiting
London, United Kingdom, SE19 9RT
Sarah Cannon Research Institute UK Recruiting
London, United Kingdom, W1G 6AD
The Christie NHS Foundation Trust Institute of Cancer Sciences, University of Manchester Recruiting
Manchester, United Kingdom, M20 4BX
Royal Marsden Recruiting
Sutton, United Kingdom, SM2 5PTT
Sponsors and Collaborators
Taiho Oncology, Inc.

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02965885     History of Changes
Other Study ID Numbers: TAS-116-101
10058010 ( Other Identifier: Taiho Oncology, Inc. )
2015-005328-24 ( EudraCT Number )
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taiho Oncology, Inc.:
Phase I
Solid Tumors
Pharmacokinetics
Pharmacodynamics
MTD
TAS116
HSP90 Inhibitor
Neoplasms
HER2 positive MBC
NSCLC EGFR
NSCLC ALK positive