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A Study of TAS-116 in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02965885
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE November 10, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE July 10, 2017
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • 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 ]
  • 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. ]
  • Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Part C) [ Time Frame: Up to 2 Years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B) [ Time Frame: 21 days in Cycle 1 ]
  • 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 ]
  • Disease Control Rate using RECIST 1.1 (Parts A, B, and C) [ Time Frame: Up to last participant completes at least 6 months ]
  • Duration of Response (Part C) [ Time Frame: Up to last participant completes at least 6 months ]
  • Progression Free Survival (Part C) [ Time Frame: Up to last participant completes at least 6 months ]
  • Overall Survival [ Time Frame: Up to last participant completes at least 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B) [ Time Frame: 21 days in Cycle 1 ]
  • 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 ]
  • Disease Control Rate using RECIST 1.1 (Parts A, B, and C) [ Time Frame: Up to 2 Years ]
  • Duration of Response (Part C) [ Time Frame: Up to 2 Years ]
  • Progression Free Survival (Part C) [ Time Frame: Up to 2 Years ]
  • Overall Survival [ Time Frame: Up to last participant completes at least 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of TAS-116 in Patients With Solid Tumors
Official Title  ICMJE A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: TAS-116
Intervention: Drug: TAS-116
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
31
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2016)
250
Actual Study Completion Date  ICMJE May 3, 2019
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02965885
Other Study ID Numbers  ICMJE TAS-116-101
10058010 ( Other Identifier: Taiho Oncology, Inc. )
2015-005328-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taiho Oncology, Inc.
Study Sponsor  ICMJE Taiho Oncology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taiho Oncology, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP