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Androgen Biosynthesis Inhibitor
TAVT-45 (Abiraterone Acetate) Granules in Patients With 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
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 • NCT0488750617%
Hypertension
11%
COVID-19
9%
Alanine aminotransferase increased
9%
Hot flush
7%
Constipation
7%
Haematuria
7%
Blood alkaline phosphatase increased
6%
Aspartate aminotransferase increased
6%
Proteinuria
6%
Asthenia
6%
Diarrhoea
6%
Fatigue
6%
Arthralgia
6%
Nausea
4%
Oedema peripheral
2%
Cervical vertebral fracture
2%
Lymphoproliferative disorder
2%
Urinary tract infection
2%
Syncope
2%
Cardio-respiratory arrest
2%
Acute kidney injury
2%
Anaemia
2%
Hepatotoxicity
2%
Myocardial ischaemia
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Tavanta TherapeuticsLead Sponsor
Kim Prescott, MBChB, MFPMStudy DirectorTMC Pharma Services Ltd
Andreas Maetzel, MD, PhDStudy ChairTavanta Therapeutics inc.