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Androgen Biosynthesis Inhibitor

TAVT-45 for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by Tavanta Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average over day 9 and day 10

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing TAVT-45, a new drug for serious prostate cancer. It targets patients whose cancer either still responds or no longer responds to treatment that lowers hormones. The drug works by lowering testosterone levels to help control the cancer.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average over day 9 and day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average over day 9 and day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and average over day 9 and day 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CR-ITT

Secondary study objectives

Percent of Subjects With PSA-50 Response, mITT

Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CS-ITT

Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), mITT

Side effects data

From 2022 Phase 3 trial • 107 Patients • NCT04887506

17%

Hypertension

11%

COVID-19

Alanine aminotransferase increased

Hot flush

Constipation

Haematuria

Blood alkaline phosphatase increased

Aspartate aminotransferase increased

Proteinuria

Asthenia

Diarrhoea

Fatigue

Arthralgia

Nausea

Oedema peripheral

Cervical vertebral fracture

Lymphoproliferative disorder

Urinary tract infection

Syncope

Cardio-respiratory arrest

Acute kidney injury

Anaemia

Hepatotoxicity

Myocardial ischaemia

100%

80%

60%

40%

20%

Study treatment Arm

TAVT-45

R-AA (Zytiga)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TAVT-45Experimental Treatment2 Interventions

TAVT-45 administered twice daily as a 1 x sachet containing TAVT-45 (250 mg abiraterone acetate) + Prednisone (5mg once or twice daily, depending on prostate cancer population). TAVT-45 administered approximately every 12 hours without respect to food. Patients treated for 84 days.

Group II: Reference abiraterone acetate (Zytiga®) - R-AAActive Control2 Interventions

Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) administered once daily as (2 x 500mg Zytiga tablets) + Prednisone (5mg once or twice daily, depending on prostate cancer population). R-AA administered once daily either ≥ 1 hour before or ≥ 2 hours after a meal. Patients treated for 84 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAVT-45

2021

Completed Phase 3

~110

Prednisone

2014

Completed Phase 4

~2500