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Metastatic Castration Resistant Prostate CancerPhase 1NCT02566772

Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

A Phase 1 study testing TAS3681 in people with Metastatic Castration Resistant Prostate Cancer, run by Taiho Oncology, Inc. at 33 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this trial is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase) and to further evaluate safety and preliminary efficacy of TAS3681 at the MTD/recommended dose (Expansion Phase). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
TAS3681
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
33 sitesin 4 countries
Study dates
Mar 2016to 26 Apr 2024
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male ≥18 years of age
  • Histological or cytological evidence of metastatic castrate resistant prostate cancer (excluding neuroendocrine differentiation and small cell histology) who are castration resistant and have:
  • Dose escalation: documented progression defined in PCWG3 and/or intolerance to abiraterone and/or enzalutamide therapy, as well as 1 or more chemotherapies.
  • Expansion:
  • Group A: documented progression after abiraterone or enzalutamide and chemotherapy consisting of no more than 2 prior taxane-based therapies
  • Group B: documented progression after only abiraterone or enzalutamide therapy without any chemotherapy
Show all 14Show fewer
  • Measurable disease per RECIST 1.1 and/or bone metastases
  • ECOG performance status of ≤1 on Day 1 Cycle 1
  • Ongoing androgen deprivation with serum testosterone <50 ng/dL
  • Expansion Phase only: willingness to undergo baseline core biopsies, if feasible
  • Ability to take medication orally
  • Adequate organ function
  • Agree to use effective contraception during the study and for 30 days after the last dose of TAS3681
  • Willing to comply with scheduled visits and procedures

Who cannot join

  • QTcF ≥ 450 ms, history of QTc prolongation or predisposition for QTc prolongation or family history of sudden cardiac death or QT prolongation
  • History or presence of heart failure or left ventricular dysfunction with ejection fraction <40% within the previous 6 months; if >6 months cardiac function within normal limits and free of cardiac-related symptoms
  • History or presence of atrial fibrillation, atrial flutter, or paroxysmal supraventricular tachycardia; the presence or history of ventricular arrhythmias including ventricular fibrillation and ventricular tachycardia
  • Presence of cardiac pacemaker or implantable cardioverter-defibrillator
  • History or presence of bradycardia or conduction abnormalities
  • History or presence of cardiac arrest or unexplained syncope
Show all 15Show fewer
  • Hypokalemia
  • History of myocardial infarction or severe unstable angina
  • Any medication administered within 2 weeks prior to 1st dose of TAS3681 that is known to prolong the QT interval or be arrhythmogenic
  • Received G-CSF, radiotherapy for extended field, anticancer chemotherapy, investigational agents, or major surgery within 4 weeks of study drug administration; receipt of anticoagulant or CYP3A inhibitor within 2 weeks of study drug administration
  • Serious illness or medical condition that could affect the safety or tolerability of study treatments
  • Received prior treatment with TAS3681
  • User of herbal products
  • Any condition or reason that in the opinion of the investigator, interferes with the ability of the participant to participate in the trial
  • To be eligible to participate in the food effect assessment (Escalation Phase only), participants must not have a history or presence of any clinically significant abnormality involving the gastrointestinal tract and an inability to fast for a minimum of 8 hours

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

United States11 sites

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Premier Oncology Group

    Edison, New Jersey, 08837

  • UMMC-Cancer Center and Research Institute

    Jackson, Missouri, 39213

  • University of Wisconsin-Carbone Cancer Center

    Madison, Wisconsin, 53705

  • MSKCC

    New York, New York, 10065

  • GU Research Network / Urology Cancer Center

    Omaha, Nebraska, 68130

  • Univeristy of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Florida Cancer Specialists & Research Institute

    Sarasota, Florida, 34232

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

France10 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Léon BERARD

    Lyon, 69008

  • Hospices Civils de Lyon

    Lyon

  • Institut Paoli Calmettes

    Marseille, 13273

  • Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • HEGP- Hôpital Européen Georges Pompidou

    Paris, 75015

  • Centre eugenie Marquis

    Rennes, 35042

  • Hopital Foch

    Suresnes, 92151

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Institut Catala d Oncologia - L Hospitalet de Llobregat

    Barcelona, 08908

  • Hospital Provincial de Castellon

    Castellana, 12002

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitari Parc Taulí

    Sabadell, 08208

  • Hospital Marques de Valdecilla

    Santander, 39008

Other trials in Spain

United Kingdom5 sites

  • Cambridge University Hospitals NHS Foundation

    Cambridge, CB2 0QQ

  • Sarah Cannon Research Institute UK

    London, England

  • The Christie NHS Foundation Trust- The Christie Clinic

    Manchester, Greater Manchester, M20 4BX

  • Royal Marsden Hospital (RMH) NHS Foundation Trust (DDU)

    Sutton, Surrey, SM2 5PT

  • Royal Marsden Hospital (RMH) NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability and Pharmacokinetic Study of TAS3681 in Patients With Metastatic Castration Resistant Prostate Cancer

The purpose of this trial is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase) and to further evaluate safety and preliminary efficacy of TAS3681 at the MTD/recommended dose (Expansion Phase).

Read the detailed description

This is a first in human, multinational, Phase 1, open-label study of TAS3681 evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC) for which there is no standard therapy. Eligible participants will be enrolled to evaluate safety and determine the MTD/recommended dose for TAS3681, including a preliminary evaluation of food effect and antitumor activity. The study will be conducted in 2 parts, Dose Escalation (Enrollment closed) and Expansion (Enrollment Closed). Patients who are continuing to receive clinical benefit may receive drug in the extension part of the study after escalation and expansion are completed.

Being tested
TAS3681
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS3681Drug

    TAS3681 will be provided as 100 mg tablets to be administered orally in 28-day cycles. The number of cycles is approximately 6, or until discontinuation criteria is met.

Study groups in NCT02566772
Study groupRoleWhat they receive
TAS3681ExperimentalAll participants will receive TAS3681 in 28-day cycles. The Escalation phase includes participants who have progressed after abiraterone, enzalutamide and chemotherapy. Eleven dose escalation cohorts are planned, one of which includes a preliminary assessment of food effect. The MTD/recommended dose for further development will be used for participants in the Expansion Phase. The Expansion Phase will enroll participants who have progressed after abiraterone or enzalutamide with chemotherapy consisting of no more than 2 prior taxane-based therapies (Group A) or without any chemotherapy (Group B). Participants receive TAS3681 until discontinuation criteria are met.
Receives: Drug: TAS3681

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with dose-limiting toxicities

    Measured: Through 1 month

  2. Escalation Phase: Number of patients with treatment-emergent adverse events and significant ECG abnormalities

    Based on treatment-emergent adverse events, serious adverse events (SAEs), clinical laboratory tests, vital signs, 12-lead electrocardiograms (ECGs)

    Measured: Through 6 months (or until patient discontinuation)

  3. Expansion Phase: Overall Response Rate (ORR)

    ORR based on investigator-assessed radiographic response per PCWG3/modified RECIST 1.1

    Measured: Through 6 months (or until patient discontinuation)

Secondary outcomes (15)

  1. Escalation Phase: Prostate Specific Antigen (PSA) response

    Measured: Up to 6 months (or until patient discontinuation)

  2. Escalation Phase: Time to PSA progression

    Measured: Up to 6 months (or until patient discontinuation)

  3. Escalation Phase: Maximum concentration of TAS3681 in plasma

    Measured: Through Day 15 in Cycle 1 (each cycle is 28 days)

  4. Escalation Phase: Time to reach maximum concentration of TAS3681

    Measured: At Day 15 in Cycle 1 (each cycle is 28 days)

  5. Escalation Phase: Area under the concentration-time curve of TAS3681

    Measured: Through Day 15 in Cycle 1 (each cycle is 28 days)

  6. Escalation Phase: Terminal half-life time of TAS3681

    Measured: Through Day 15 in Cycle 1 (each cycle is 28 days)

  7. Escalation Phase: Accumulation ratio of TAS3681

    Measured: Through Day 15 in Cycle 1 (each cycle is 28 days)

  8. Escalation Phase: Tumor response per PCWG3/RECIST 1.1 including ORR, and duration of response (DOR)

    Measured: Through 6 months ( or until patient discontinuation)

  9. Expansion Phase: Prostate Specific Antigen (PSA) response

    Measured: Up to 6 months (or until patient discontinuation)

  10. Expansion Phase: Number of patients with treatment-emergent adverse events and significant ECG abnormalities

    Based on treatment-emergent adverse events, serious adverse events (SAEs), clinical laboratory tests, vital signs, 12-lead ECGs

    Measured: Through 6 months (or until patient discontinuation)

  11. Expansion Phase: Maximum concentration of TAS3681 in plasma

    Measured: Through Day 15 during Cycle 1 (each cycle is 28 days)

  12. Expansion Phase: Time to reach maximum concentration of TAS3681

    Measured: Through Day 15 during Cycle 1 (each cycle is 28 days)

  13. Expansion Phase: Area under the concentration-time curve of TAS3681

    Measured: Through Day 15 during Cycle 1 (each cycle is 28 days)

  14. Expansion Phase: Terminal half-life time of TAS3681

    Measured: Through Day 15 of Cycle 1 (each cycle is 28 days)

  15. Expansion:Tumor response measures including duration of response (DOR), radiologic progression-free survival (rPFS), overall survival (OS), clinical benefit rate (CBR; percentage of participants with complete response, partial response or stable disease)

    Measured: Through 6 months (or until patient discontinuation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2015 (estimated)
  2. Study startMar 2016
  3. Primary completion9 Aug 2022
  4. Study completion26 Apr 2024

Resources

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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02566772
Sponsor's protocol ID
TO-TAS3681-101
Other IDs
2015-002745-55, 2015
Status last verified
Aug 2024
First submitted
25 Sep 2015
Last updated
3 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAS3681 in people with Metastatic Castration Resistant Prostate Cancer, run by Taiho Oncology, Inc. at 33 sites in 4 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 14 inclusion and 15 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 3 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 33 sites in United States, France, Spain, United Kingdom. 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 with dose-limiting toxicities (time frame: Through 1 month). 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?

On the ClinicalTrials.gov record for NCT02566772.

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 3 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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