Clinical trials: Abiraterone Acetate
Prostate Cancer
Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of…
- Trial name
- NCT01485861
- Testing
- Abiraterone, Apitolisib, Ipatasertib
- Where
- 59 sites in United States, Czechia and 7 more
- Volunteers
- 298 people
- Sponsor
- Genentech, Inc.
Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine safety of the combination and evaluate in a…
- Trial name
- NCT02123758
- Testing
- Abiraterone Acetate, Prednisone, JNJ-56021927
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 57 people
- Sponsor
- Aragon Pharmaceuticals, Inc.
Healthy Volunteers
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men
The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men.
- Trial name
- NCT01588782
- Testing
- Period 1: Abiraterone, Period 2: Abiraterone/Ketoconazole
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week…
- Conditions
- Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer
- Trial name
- NCT04666129
- Testing
- Relugolix, Abiraterone, Prednisone
- Where
- 16 sites in United States
- Volunteers
- 48 people
- Sponsor
- Sumitomo Pharma America, Inc.
Advanced Solid Tumor
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in…
- Trial name
- NCT06421935
- Testing
- M9466, Tuvusertib, Abiraterone acetate
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 60 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either…
- Trial name
- MEVPRO-1 (NCT06551324)
- Testing
- PF-06821497, Docetaxel, Enzalutamide
- Where
- 224 sites in United States, Argentina and 21 more
- Volunteers
- 609 people
- Sponsor
- Pfizer
Metastatic Castration Resistant Prostate Cancer
Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer
Abiraterone acetate is an orally effective CYP17 inhibitor, which is metabolized into abiraterone in the body, and its inhibitory activity against CYP17 is 10-30 times that of ketoconazole.
- Trial name
- NCT04056754
- Testing
- Abiraterone Acetate, Prednisone
- Where
- 16 sites in China
- Volunteers
- 268 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Prostatic Neoplasms
Phase 1 Study of Abiraterone Acetate in Castration-resistant Prostate Cancer
The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to select the recommended dose of JNJ-212082 for patients with castration resistant prostate cancer.
- Trial name
- NCT01186484
- Testing
- JNJ-212082
- Where
- 5 sites in Japan
- Volunteers
- 27 people
- Sponsor
- Janssen Pharmaceutical K.K.
Prostate Cancer
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer…
- Trial name
- NCT00887198
- Testing
- Abiraterone acetate, Prednisone
- Where
- 134 sites in United States, Australia and 9 more
- Volunteers
- 1,088 people
- Sponsor
- Janssen Research & Development, LLC
Prostatic Neoplasms
Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs…
- Trial name
- ERA 223 (NCT02043678)
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Abiraterone, Prednisone/Prednisolone
- Where
- 163 sites in United States, Australia and 17 more
- Volunteers
- 806 people
- Sponsor
- Bayer
Prostate Cancer
Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy
The purpose of the study is to determine the safety and clinical benefit of the combinations of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer patients.
- Trial name
- NCT01867710
- Testing
- Abiraterone Acetate, Prednisone 5 mg twice daily, Prednisone 5 mg once daily
- Where
- 17 sites in Belgium, Germany and 2 more
- Volunteers
- 164 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Prostate Cancer
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in…
- Trial name
- NCT00924469
- Testing
- Abiraterone, Leuprolide, Prednisone
- Where
- 4 sites in United States
- Volunteers
- 58 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants
The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated…
- Trial name
- NCT02230046
- Testing
- Abiraterone acetate (Treatment A), Abiraterone acetate (Treatment B)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Metastatic Castration-resistant Prostate Cancer
PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Trial name
- NCT04556617
- Testing
- PLX2853 20 mg, Olaparib, Abiraterone acetate
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 19 people
- Sponsor
- Opna Bio LLC
Prostate Cancer
PK and Dose Escalation and Expansion Study of DST-2970
This is a Phase I multi-center, open-label, study of DST-2970 to determine the MTD, overall safety/tolerability, PK/pharmacodynamic parameters, and efficacy in prostate cancer patients.The study will include a dose escalation…
- Trial name
- NCT04291664
- Testing
- Abiraterone Acetate, Prednisone 5Mg Tab, DST-2970 (Abiraterone)
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- DisperSol Technologies, LLC
Metastatic Prostate Cancer
One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
This is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid).
- Trial name
- NCT02962284
- Testing
- abiraterone acetate with Methylprednisolone
- Volunteers
- 20 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Prostatic Neoplasms
A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)
The primary objective in this study is to evaluate bone scan response at Week 24 based on the quantified technetium-99 bone scan lesion area (BSLA).
- Trial name
- NCT02034552
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Abiraterone acetate, Prednisone
- Where
- 19 sites in United States
- Volunteers
- 68 people
- Sponsor
- Bayer
Hepatic Impairment
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing…
- Trial name
- NCT01516047
- Testing
- Cohort 1, Cohort 2
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
A Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation in Healthy Adult Volunteers
The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body) of the solution formulation to the tablet…
- Trial name
- NCT01362764
- Testing
- Abiraterone acetate suspension Formulation 1, Abiraterone acetate suspension Formulation 2, Abiraterone acetate tablets
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cougar Biotechnology, Inc.
Prostate Neoplasms
An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001
The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this…
- Trial name
- NCT01664728
- Testing
- Abiraterone acetate, Glucocorticoid
- Where
- United Kingdom
- Volunteers
- 54 people
- Sponsor
- Janssen Research & Development, LLC