Clinical trials: Enzalutamide
Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care…
- Trial name
- NCT07570979
- Testing
- INR731, Enzalutamide, Abiraterone
- Where
- 13 sites in United States, Australia and 6 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines: abiraterone, apalutamide, enzalutamide.
- Trial name
- NCT06151418
- Testing
- Novel hormonal therapy
- Where
- United States
- Volunteers
- 2,313 people
- Sponsor
- Pfizer
Metastatic Castration-Resistant Prostate Cancer
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected…
- Trial name
- InavoPC (NCT07287150)
- Testing
- Inavolisib, Enzalutamide, Abiraterone
- Where
- 48 sites in United States, Australia and 10 more
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Urothelial Carcinoma, Renal Cell Carcinoma
Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types…
- Conditions
- Urothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Castration-resistant Prostate Cancer
- Trial name
- NCT03170960
- Testing
- cabozantinib, atezolizumab
- Where
- 124 sites in United States, Australia and 7 more
- Volunteers
- 914 people
- Sponsor
- Exelixis
Squamous Cell Carcinoma of the Head and Neck (SCCHN), Metastatic Castration Resistant Prostate Cancer (mCRPC)
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
Evaluation of the combination of avelumab + bempegaldesleukin (NKTR-214 ) in locally advanced squamous cell carcinoma of the head and neck ( metastatic SCCHN) and avelumab + bempegaldesleukin (NKTR-214) + talazoparib or…
- Trial name
- NCT04052204
- Testing
- avelumab, Bempegaldesleukin, talazoparib
- Where
- 5 sites in United States, Belgium and 2 more
- Volunteers
- 3 people
- Sponsor
- Pfizer
Metastatic Castration-resistant Prostate Cancer, Androgen Resistant Prostatic Cancer
Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent
To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured…
- Trial name
- VERACITY (NCT04844749)
- Testing
- VERU-111, Enzalutamide, Abiraterone
- Where
- 40 sites in United States
- Volunteers
- 105 people
- Sponsor
- Veru Inc.
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)
The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received…
- Trial name
- EvoPAR-PR05 (NCT07711002)
- Testing
- Saruparib, Enzalutamide, Darolutamide
- Where
- 210 sites in United States, Austria and 19 more
- Volunteers
- 1,330 people
- Sponsor
- AstraZeneca
Prostate Cancer
A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.
- Trial name
- NCT07230106
- Testing
- HS-20093 for Injection, SHR3680 Tablet, Abiraterone Tablet
- Where
- 2 sites in China
- Volunteers
- 218 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Prostatic Neoplasms
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
The purpose of this registry study is to longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for participants with high-risk metastatic hormone-naive prostate cancer (mHNPC) in the real-world setting in…
- Trial name
- NCT04034095
- Testing
- Androgen-deprivation Therapy (ADT), Bicalutamide, Abiraterone
- Where
- 77 sites in Japan
- Volunteers
- 979 people
- Sponsor
- Janssen Pharmaceutical K.K.
Pharmacokinetics of Dextromethorphan, Pharmacokinetics of Caffeine
A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer
This study evaluates how once daily enzalutamide affects the metabolism of caffeine and dextromethorphan in men with prostate cancer by measuring concentrations of these drugs and their metabolites in plasma.
- Conditions
- Pharmacokinetics of Dextromethorphan, Pharmacokinetics of Caffeine, Prostate Cancer
- Trial name
- NCT02225093
- Testing
- Caffeine, Dextromethorphan, Enzalutamide
- Where
- Moldova
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Europe B.V.
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).
In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy…
- Trial name
- PHENIX (NCT03896984)
- Testing
- Radium-223 (Xofigo, BAY88-8223), Abiraterone, Enzalutamide
- Where
- United States
- Volunteers
- 346 people
- Sponsor
- Bayer
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as…
- Trial name
- NCT07226986
- Testing
- AMO959, AAA617, Enzalutamide
- Where
- 25 sites in United States, Australia and 5 more
- Volunteers
- 123 people
- Sponsor
- Novartis Pharmaceuticals
Glioblastoma, Melanoma Stage IV
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors.
- Conditions
- Glioblastoma, Melanoma Stage IV, Breast Cancer, Prostate Cancer
- Trial name
- NCT04478279
- Testing
- ST101, Temozolomide, Radiation
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 125 people
- Sponsor
- Sapience Therapeutics
Non-metastatic Castration-resistant Prostate Cancer
An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings
This is an observational study in which patient data from the past on men with non-metastatic castration-resistant prostate cancer are studied.
- Trial name
- DEAR (NCT05362149)
- Testing
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
- Where
- United States
- Volunteers
- 870 people
- Sponsor
- Bayer
Metastatic Hormone-Sensitive Prostate Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)-China Extension
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC.
- Trial name
- NCT04934722
- Testing
- Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT)
- Where
- 24 sites in China
- Volunteers
- 186 people
- Sponsor
- Merck Sharp & Dohme LLC
Hormone Sensitive Prostate Cancer, Prostate Cancer
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
- Conditions
- Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Trial name
- NCT02319837
- Testing
- Enzalutamide, Leuprolide Open Label
- Where
- 255 sites in United States, Australia and 15 more
- Volunteers
- 1,068 people
- Sponsor
- Pfizer
Neoplasms
Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors
This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral ipatasertib (GDC-0068) administered in combination with either docetaxel (Arm A), or…
- Trial name
- NCT01362374
- Testing
- 5-FU, Docetaxel, Enzalutamide
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 122 people
- Sponsor
- Genentech, Inc.
Metastatic Castration Resistant Prostate Cancer
A Study Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch
This is a study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and related changes after drug switch in Chinese patients with metastatic castration-resistant prostate cancer.
- Trial name
- NCT03778047
- Testing
- Enzalutamide, HC1119
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hinova Pharmaceuticals Inc.
Prostatic Neoplasms
Study of ORIC-101 in Combination With Enzalutamide
The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with enzalutamide (Xtandi®) when…
- Trial name
- NCT04033328
- Testing
- ORIC-101, enzalutamide 40 MG oral capsule [Xtandi]
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- ORIC Pharmaceuticals
Prostate Cancer
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic…
- Trial name
- AcTFirst (NCT06855277)
- Testing
- AAA817, ARPI, Standard of Care
- Where
- 106 sites in United States, Australia and 10 more
- Volunteers
- 940 people
- Sponsor
- Novartis Pharmaceuticals