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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR XTANDI


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All Clinical Trials for Xtandi

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-na├»ve 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.
NCT00510718 ↗ A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer Completed Astellas Pharma Inc Phase 1 2007-07-23 This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗ A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer Completed Medivation LLC, a wholly owned subsidiary of Pfizer Inc. Phase 1 2007-07-23 This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗ A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer Completed Medivation, Inc. Phase 1 2007-07-23 This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Xtandi

Condition Name

Condition Name for Xtandi
Intervention Trials
Prostate Cancer 43
Stage IV Prostate Cancer 13
Castration-Resistant Prostate Carcinoma 12
Metastatic Prostate Carcinoma 9
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Condition MeSH

Condition MeSH for Xtandi
Intervention Trials
Prostatic Neoplasms 120
Carcinoma 20
Adenocarcinoma 18
Breast Neoplasms 9
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Clinical Trial Locations for Xtandi

Trials by Country

Trials by Country for Xtandi
Location Trials
United States 576
United Kingdom 107
Canada 80
France 72
Italy 67
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Trials by US State

Trials by US State for Xtandi
Location Trials
California 38
New York 33
Texas 30
Illinois 26
Maryland 25
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Clinical Trial Progress for Xtandi

Clinical Trial Phase

Clinical Trial Phase for Xtandi
Clinical Trial Phase Trials
Phase 4 9
Phase 3 14
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Xtandi
Clinical Trial Phase Trials
Completed 46
Recruiting 38
Active, not recruiting 31
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Clinical Trial Sponsors for Xtandi

Sponsor Name

Sponsor Name for Xtandi
Sponsor Trials
Medivation, Inc. 47
Astellas Pharma Inc 31
National Cancer Institute (NCI) 24
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Sponsor Type

Sponsor Type for Xtandi
Sponsor Trials
Industry 182
Other 130
NIH 24
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