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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR ENZALUTAMIDE

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Clinical Trials for Enzalutamide

Trial ID Title Status Sponsor Phase Summary
NCT00268476 STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial Recruiting Medical Research Council Phase 2/Phase 3 Prostate cancers depend upon the male hormone testosterone for their growth. Lowering testosterone levels (either by removing all or part of both testes, or by giving anti-hormone treatment) slows the growth of prostate cancers. This type of treatment is called hormone treatment and is often used when prostate cancers have spread outside of the prostate gland. Although hormone treatment is usually successful at stopping the cancer growing for a period of time, the cancer will begin to grow again in most men. There are increasing numbers of treatments available for advanced prostate cancer. These treatments are usually used in prostate cancer when hormone treatment is no longer effective and the cancer has started to grow again. The aim of this trial, which is called STAMPEDE, is to assess five of these treatments, given earlier in the course of the disease in combination with hormone treatment. The treatments assessed during the trial are: 1. Zoledronic acid: Prostate cancer cells can spread to bones and weaken them. Zoledronic acid is a drug that reduces bone destruction and hardens bones. This may make them more resistant to attack by cancer cells. 2. Docetaxel: A drug that stops cells replicating, Docetaxel is currently being used to treat a range of cancers including lung, breast and ovarian cancer as well as prostate cancer. Docetaxel is already known to prolong survival in men with relapsed metastatic prostate cancer. 3. Celecoxib: An aspirin-like drug that is used to treat arthritis. Celecoxib slows down the growth of cancer cells in the laboratory. We wished to see if it had the same effect on cancer cells in patients. Recruitment to new patients for the evaluation of this drug is finished as a pre-planned interim analysis failed to demonstrate sufficient activity. 4. Abiraterone (included from protocol version 8.0): An inhibitor of steroid hormone synthesis that blocks prostate cancer cells from generating their own male hormones. This is thought to be a major way in which prostate cancer cells resume growth following castration based therapies. This agent is given along with prednisolone and is already known to prolong survival when given to men following failure of docetaxel chemotherapy. 5. Prostate radiotherapy (included from protocol version 9.0): Treatment with high-energy x-rays targeted to the prostate gland. This treatment is now mandatory for patients with cancer that is confined to the prostate gland as large trials have shown it improves survival times. We are interested in whether we should give radiotherapy to the prostate if the cancer has already spread. 6. Enzalutamide (included from protocol version 12.0): This is a blocker of androgen receptors. These stimulate the cancer when hormone therapies have failed. Enzalutamide may be mutually complementary to abiraterone in terms of blocking mechanisms of resistance. The agent prolongs survival when given to men following failure of docetaxel chemotherapy. STAMPEDE will look at the effect of combining one or two of the treatments described above with hormone treatment. A computer program will be used to allocate which treatment the patient receives, using a chance process. The trial will look at the effects of the combined treatments on quality of life and find out whether the new treatment combinations increase the time when the cancer is not growing and ultimately results in patients living longer. The study will also look at which treatment provides the greater value for money for the health service. More than 8,000 patients will join the trial with answers becoming available over 7 to 12 years.
NCT00510718 A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer Active, not recruiting Medivation, Inc. Phase 1 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.
NCT00974311 Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy Active, not recruiting Astellas Pharma Inc Phase 3 This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Enzalutamide

Condition Name

Condition Name for Enzalutamide
Intervention Trials
Prostate Cancer 76
Stage IV Prostate Cancer 15
Castration-Resistant Prostate Cancer 14
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Condition MeSH

Condition MeSH for Enzalutamide
Intervention Trials
Prostatic Neoplasms 172
Adenocarcinoma 18
Breast Neoplasms 14
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Clinical Trial Locations for Enzalutamide

Trials by Country

Trials by Country for Enzalutamide
Location Trials
United States 795
Canada 90
United Kingdom 71
Australia 57
Spain 47
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Trials by US State

Trials by US State for Enzalutamide
Location Trials
New York 48
California 43
Texas 40
Maryland 40
Michigan 34
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Clinical Trial Progress for Enzalutamide

Clinical Trial Phase

Clinical Trial Phase for Enzalutamide
Clinical Trial Phase Trials
Phase 4 10
Phase 3 19
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Enzalutamide
Clinical Trial Phase Trials
Recruiting 116
Not yet recruiting 38
Active, not recruiting 35
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Clinical Trial Sponsors for Enzalutamide

Sponsor Name

Sponsor Name for Enzalutamide
Sponsor Trials
Medivation, Inc. 55
Astellas Pharma Inc 38
National Cancer Institute (NCI) 31
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Sponsor Type

Sponsor Type for Enzalutamide
Sponsor Trials
Other 195
Industry 192
NIH 32
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
Merck
Chinese Patent Office
Johnson and Johnson
Mallinckrodt
US Army
QuintilesIMS
Julphar

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