What side effects are associated with this type of intervention?

Common treatments for metastatic castration-resistant prostate cancer (mCRPC) include androgen receptor inhibitors such as enzalutamide, apalutamide, and darolutamide, as well as taxane-based chemotherapies like docetaxel and cabazitaxel. Androgen receptor inhibitors can cause side effects such as fatigue, hypertension, and a higher risk of falls and fractures. Darolutamide is noted for fewer central nervous system side effects compared to enzalutamide and apalutamide. Taxane-based chemotherapies, like docetaxel and cabazitaxel, commonly cause neutropenia, neuropathy, alopecia, and gastrointestinal symptoms. These treatments aim to manage symptoms and improve quality of life but come with a range of potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for metastatic castration-resistant prostate cancer (CRPC). Notable approvals include androgen receptor pathway inhibitors such as enzalutamide and abiraterone, which target androgen signaling crucial for prostate cancer growth. Taxane-based chemotherapies like docetaxel and cabazitaxel have also been approved, offering significant survival benefits. Additionally, radioligand therapy with lutetium Lu 177 vipivotide tetraxetan has been approved for PSMA-positive metastatic CRPC, demonstrating improved progression-free and overall survival. These treatments have undergone rigorous safety and tolerability assessments, similar to the ongoing evaluation of TAS3681.

What other types of research exist?

Promising novel alternatives to TAS3681 for prostate cancer patients in 2024 include: 1) Lutetium Lu 177 vipivotide tetraxetan, which has shown high response rates, low toxic effects, and pain reduction in metastatic castration-resistant prostate cancer (mCRPC) patients. 2) Talazoparib, a PARP inhibitor, which demonstrated significant efficacy in mCRPC patients with DNA damage repair mutations, particularly BRCA1/2. 3) TAS-115, a multikinase inhibitor, which showed anti-tumor activity and acceptable tolerability in CRPC patients with bone metastases. These alternatives have shown promising results in recent clinical trials and may offer effective treatment options.

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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 below

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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:

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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.

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I haven't taken any heart rhythm-affecting medication in the last 2 weeks.

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I haven't had certain treatments or major surgery in the last 4 weeks, nor taken specific drugs in the last 2 weeks.

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I have been treated with TAS3681 before.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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

0 / 14Eligibility criteria met

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.