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Androgen Receptor Degrader
TAS3681 for Prostate Cancer
Phase 1
Waitlist Available
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male ≥18 years of age
Measurable disease per RECIST 1.1 and/or bone metastases
Must not have
History or presence of bradycardia or conduction abnormalities
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of week 4, at the end of every 12 weeks, and end of every 12 weeks through study completion, an average of 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests TAS3681, a new drug, for safety and effectiveness in patients with advanced prostate cancer that doesn't respond to usual treatments. It aims to find out how the drug works in the body and its impact on cancer cells.
Who is the study for?
This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread. They should be in good physical condition, able to take oral medication, have adequate organ function, and agree to use contraception. Participants must not have heart issues or be taking certain other medications.
What is being tested?
The study tests TAS3681's safety and the highest dose patients can tolerate without severe side effects (Escalation Phase), followed by further evaluation of its safety and initial effectiveness at this dose (Expansion Phase).
What are the potential side effects?
While specific side effects of TAS3681 are not listed here, common ones may include nausea, fatigue, risk of infection due to low blood cell counts, liver problems, diarrhea or constipation. Patients will be closely monitored for any heart-related side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18 or older.
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My cancer can be measured by scans or I have cancer spread to bones.
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I am fully active or can carry out light work.
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I am on hormone therapy for cancer, and my testosterone is below 50 ng/dL.
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I can take medication by mouth.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of slow heartbeat or heart signal issues.
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I have a history of irregular heartbeats or arrhythmias.
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I have a history of heart rhythm issues or sudden cardiac death in my family.
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I have had a cardiac arrest or unexplained fainting.
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I have had a heart attack or severe chest pain.
Select...
I haven't taken any heart rhythm-affecting medication in the last 2 weeks.
Select...
I haven't had certain treatments or major surgery in the last 4 weeks, nor taken specific drugs in the last 2 weeks.
Select...
I have been treated with TAS3681 before.
Select...
I use herbal products.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, end of week 4, at the end of every 12 weeks, and end of every 12 weeks through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of week 4, at the end of every 12 weeks, and end of every 12 weeks through study completion, an average of 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Escalation Phase: Number of patients with treatment-emergent adverse events and significant ECG abnormalities
Expansion Phase: Overall Response Rate (ORR)
Secondary study objectives
Expansion Phase: Number of patients with treatment-emergent adverse events and significant ECG abnormalities
Other study objectives
Change from baseline in Circulating Tumor Cell (CTC) number in blood
Number of patients with AR-v7 positivity in circulating tumor cells
Severity and impact of pain on daily function using Brief Pain Inventory - Short Form (BPI-SF).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TAS3681Experimental Treatment1 Intervention
All 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS3681
2016
Completed Phase 1
~130
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen deprivation therapy (ADT), chemotherapy, and immunotherapy. ADT reduces testosterone levels, which prostate cancer cells need to grow.
Chemotherapy, such as docetaxel, targets and disrupts rapidly dividing cancer cells. Immunotherapy, like sipuleucel-T, enhances the immune system's ability to recognize and attack cancer cells.
These treatments are vital as they provide multiple strategies to control cancer progression, improving survival and quality of life for patients.
Treat-to-target in PsA: methods and necessity.Symptomatic and quality-of-life outcomes after treatment for clinically localised prostate cancer: a systematic review.Important Treatment Outcomes for Patients with Psoriatic Arthritis: A Multisite Qualitative Study.
Treat-to-target in PsA: methods and necessity.Symptomatic and quality-of-life outcomes after treatment for clinically localised prostate cancer: a systematic review.Important Treatment Outcomes for Patients with Psoriatic Arthritis: A Multisite Qualitative Study.
Find a Location
Who is running the clinical trial?
Taiho Oncology, Inc.Lead Sponsor
78 Previous Clinical Trials
12,960 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of slow heartbeat or heart signal issues.I have a history of irregular heartbeats or arrhythmias.My prostate cancer is resistant to standard treatments and has spread.I am willing to have a biopsy before the trial starts, if it's possible.I have a history of heart rhythm issues or sudden cardiac death in my family.My heart functions well and I haven't had heart failure or poor heart pumping in the last 6 months.I have had a heart attack or severe chest pain.I haven't taken any heart rhythm-affecting medication in the last 2 weeks.I am on hormone therapy for cancer, and my testosterone is below 50 ng/dL.I have had a cardiac arrest or unexplained fainting.I haven't had certain treatments or major surgery in the last 4 weeks, nor taken specific drugs in the last 2 weeks.I use herbal products.I am a man aged 18 or older.I can take medication by mouth.My cancer can be measured by scans or I have cancer spread to bones.My organs are functioning well.I have been treated with TAS3681 before.I am fully active or can carry out light work.I don't have significant gastrointestinal issues and can fast for at least 8 hours.I do not have any serious illness that could interfere with the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: TAS3681
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.