Advanced Solid TumorsPhase 1NCT02965885
A Study of TAS-116 in Patients With Solid Tumors
A Phase 1 study testing TAS-116 in people with Advanced Solid Tumors, run by Taiho Oncology, Inc. at 12 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TAS-116
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 10 Jul 2017to 3 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United Kingdom5 sites
Division of Cancer Studies, Kings College London
London, SE19 9RT
Sarah Cannon Research Institute UK
London, W1G 6AD
The Christie NHS Foundation Trust Institute of Cancer Sciences, University of Manchester
Manchester, M20 4BX
Northern Centre for Cancer Care
Newcastle upon Tyne, England
Royal Marsden
Sutton, SM2 5PTT
Italy4 sites
Policlinico S.Orsola-Malpighi, U.O. Oncologia Medica
Bologna, 40138
Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele Oncologia Medica
Catania, 95123
Istituto Europeo di Oncologia , Sviluppo di Nuovi Farmaci per Terapie Innovative
Milan, 20141
Regina Elena National Cancer Institute
Roma, 00144
United States3 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
US Oncology - Virginia Cancer Specialists, P.C.
Fairfax, Virginia, 86885
Greenville Health System, Institute for Translational Oncology Research
Greenville, South Carolina, 29605
About this study
Official title: A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- TAS-116
- Keywords
- Phase I, Solid Tumors, Pharmacokinetics, Pharmacodynamics, MTD, TAS116, HSP90 Inhibitor, Neoplasms, HER2 positive MBC, NSCLC EGFR, NSCLC ALK positive
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-116Drug
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 group | Role | What they receive |
|---|---|---|
| TAS-116 | Experimental | Not described Receives: Drug: TAS-116 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 21 days in Cycle 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Parts A, B and C)
Measured: 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)
Measured: Up to 2 Years
Secondary outcomes (6)
Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B)
Measured: 21 days in Cycle 1
Area under the plasma drug concentration-time curve (AUC) after administration of TAS-116 (Parts A and B)
Measured: 21 days in Cycle 1
Disease Control Rate using RECIST 1.1 (Parts A, B, and C)
Measured: Up to last participant completes at least 6 months
Duration of Response (Part C)
Measured: Up to last participant completes at least 6 months
Progression Free Survival (Part C)
Measured: Up to last participant completes at least 6 months
Overall Survival
Measured: Up to last participant completes at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start10 Jul 2017
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965885
- Sponsor's protocol ID
- TAS-116-101
- Other IDs
- 10058010, 2015-005328-24, 2015
- Status last verified
- Aug 2024
- First submitted
- 10 Nov 2016
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02965885
- Acronym / sponsor ID
- TAS-116-101
- Conditions
- Advanced Solid Tumors
- Keywords
- Phase I, Solid Tumors, Pharmacokinetics, Pharmacodynamics, MTD, TAS116, HSP90 Inhibitor, Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-116 | Experimental | Drug: TAS-116 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-116TAS-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. | Drug | TAS-116 |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAS-116 in people with Advanced Solid Tumors, run by Taiho Oncology, Inc. at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Italy, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.