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Last Updated: September 24, 2021

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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 Active, not recruiting 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 Active, not recruiting 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
NCT01023061 ↗ Abiraterone Acetate, Prednisone, and Leuprolide Acetate or Goserelin Before and During Radiation Therapy in Treating Patients With Localized or Locally Advanced 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 Acetate, Prednisone, and Leuprolide Acetate or Goserelin Before and During Radiation Therapy in Treating Patients With Localized or Locally Advanced 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.
NCT01503229 ↗ Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Active, not recruiting National Cancer Institute (NCI) Phase 2 2012-12-01 This phase II trial studies how well abiraterone acetate works in treating patients with hormone-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01503229 ↗ Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Active, not recruiting University of Washington Phase 2 2012-12-01 This phase II trial studies how well abiraterone acetate works in treating patients with hormone-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01543776 ↗ Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer Active, not recruiting National Cancer Institute (NCI) Phase 2 2012-01-01 This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zytiga

Condition Name

Condition Name for Zytiga
Intervention Trials
Prostate Cancer 34
Stage IV Prostate Cancer 11
Stage IVA Prostate Cancer AJCC v8 7
Prostate Adenocarcinoma 7
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Condition MeSH

Condition MeSH for Zytiga
Intervention Trials
Prostatic Neoplasms 80
Adenocarcinoma 17
Carcinoma 8
Hypersensitivity 7
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Clinical Trial Locations for Zytiga

Trials by Country

Trials by Country for Zytiga
Location Trials
United States 207
Canada 27
Spain 20
Italy 17
United Kingdom 14
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Trials by US State

Trials by US State for Zytiga
Location Trials
California 18
Texas 16
New York 13
Washington 11
North Carolina 10
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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 14
Phase 2 50
[disabled in preview] 16
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Clinical Trial Status

Clinical Trial Status for Zytiga
Clinical Trial Phase Trials
Not yet recruiting 35
Recruiting 27
Active, not recruiting 21
[disabled in preview] 7
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Clinical Trial Sponsors for Zytiga

Sponsor Name

Sponsor Name for Zytiga
Sponsor Trials
National Cancer Institute (NCI) 19
M.D. Anderson Cancer Center 8
Janssen Scientific Affairs, LLC 8
[disabled in preview] 10
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Sponsor Type

Sponsor Type for Zytiga
Sponsor Trials
Other 93
Industry 60
NIH 21
[disabled in preview] 1
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