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Last Updated: January 26, 2023

CLINICAL TRIALS PROFILE FOR ZYTIGA


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505(b)(2) Clinical Trials for Zytiga

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT01845792 ↗ Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer Terminated Janssen Services, LLC Phase 2 2013-07-01 Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
New Combination NCT01845792 ↗ Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer Terminated University of Colorado, Denver Phase 2 2013-07-01 Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
New Formulation NCT04887506 ↗ TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer Recruiting Tavanta Therapeutics Phase 3 2021-04-14 The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Zytiga

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00268476 ↗ Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy Recruiting Medical Research Council Phase 2/Phase 3 2005-07-08 The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-naïve prostate cancer. This trial aims to see if we can improve the way in which prostate cancer is currently managed, either by adding new treatments to the standard approach or by modifying the type of hormone therapy aiming to improve quality-of-life by reducing the side effects of treatment. Each new treatment approach is compared against a control arm receiving the current standard treatments. We aim to identify treatment strategies that enable men to live longer, or as long but with an improved quality-of-life, as well as offering value for money for the health service. Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate cancer and some results are now already known. More than 10,000 men will join the trial with answers becoming available throughout the trial. New patients joining the trial from Protocol version 17.0 onwards (activated in December 2018) may be eligible to join one of two treatment comparisons, metformin (treatment group K; the "metformin comparison") and transdermal oestradiol (treatment group L; the "transdermal oestradiol comparison"). A computer program will be used to allocate which treatment each participant receives, using a chance process. Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups currently open to recruitment (June 2017) 1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE will investigate whether adding metformin to the current standard-of-care for non-diabetic men can improve all-cause survival. 2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which has been shown to suppress testosterone as effectively as standard ADT and avoid some of the side-effects. It may also help to avoid the adverse metabolic effects and fatigue and therefore improve overall quality of life compared with standard forms of ADT. STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as current standard forms of ADT. 3. Control group (Arm A): Patients allocated to this group receive the current standard-of-care ADT +/- RT +/- docetaxel.
NCT01023061 ↗ Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 2010-03-01 This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.
NCT01023061 ↗ Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer Completed University of Washington Phase 2 2010-03-01 This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zytiga

Condition Name

Condition Name for Zytiga
Intervention Trials
Prostate Cancer 44
Stage IV Prostate Cancer 11
Prostate Adenocarcinoma 11
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Condition MeSH

Condition MeSH for Zytiga
Intervention Trials
Prostatic Neoplasms 101
Adenocarcinoma 21
Carcinoma 12
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Clinical Trial Locations for Zytiga

Trials by Country

Trials by Country for Zytiga
Location Trials
United States 446
United Kingdom 71
Canada 49
Spain 32
Italy 22
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Trials by US State

Trials by US State for Zytiga
Location Trials
California 31
Texas 26
New York 22
Maryland 20
Illinois 18
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Clinical Trial Progress for Zytiga

Clinical Trial Phase

Clinical Trial Phase for Zytiga
Clinical Trial Phase Trials
Phase 4 6
Phase 3 16
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Zytiga
Clinical Trial Phase Trials
Recruiting 33
Completed 28
Active, not recruiting 24
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Clinical Trial Sponsors for Zytiga

Sponsor Name

Sponsor Name for Zytiga
Sponsor Trials
National Cancer Institute (NCI) 23
Janssen Scientific Affairs, LLC 9
M.D. Anderson Cancer Center 8
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Sponsor Type

Sponsor Type for Zytiga
Sponsor Trials
Other 115
Industry 80
NIH 25
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