Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01650194 · ClinicalTrials.gov registry record · Phase 2
A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients
A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01650194: Completed Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Astellas Pharma Global Development.
NCT01650194 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 60 participants, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01650194, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study was to explore the safety and tolerability of enzalutamide in combination with abiraterone acetate plus prednisone. Subjects diagnosed with cancer of the prostate that was getting worse and spreading to the bone despite receiving hormone treatment were enrolled and received study treatment until disease progression.
Primary Outcome
A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03).
Conditions Studied
Interventions
- DRUG enzalutamide
- DRUG abiraterone acetate
- DRUG prednisone
Study Locations (1)
Texas
- Site US2492 MD Anderson Cancer Ctr - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-07-09 |
| Est. Completion | 2018-01-04 |
| Phase | Phase 2 |
What the finished NCT01650194 record still lists
NCT01650194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which enzalutamide is the first listed.
NCT01650194 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01650194 about?
NCT01650194 is a clinical study titled "A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients". The purpose of this study was to explore the safety and tolerability of enzalutamide in combination with abiraterone acetate plus prednisone. Subjects diagnosed with cancer of the prostate that was getting worse and spreading to the bone despite receiving hormone treatment were enrolled and received...
What is the current status of trial NCT01650194?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2012-07-09. Estimated completion is 2018-01-04.
What conditions does trial NCT01650194 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT01650194?
The interventions under investigation include: enzalutamide (DRUG), abiraterone acetate (DRUG), prednisone (DRUG).
Who is sponsoring clinical trial NCT01650194?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01650194 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Castration-Resistant Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01650194's enrollment target sits among peer trials
60 38th of 69 higher than 30 of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
RECRUITING · Phase 2
-
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
RECRUITING · Phase 2
-
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
RECRUITING · Phase 2
-
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
RECRUITING · Phase 2
-
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
RECRUITING · Phase 2
-
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI