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NCT01597193 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
- 17
- Study locations
NCT01597193: Completed Phase 1 study of Breast Cancer, sponsored by Pfizer.
NCT01597193 is a Phase 1 study of Breast Cancer that has completed, run by Pfizer. The registered enrollment target is 101 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 17 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01597193, a Phase 1 study of Breast Cancer, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.
Primary Outcome
DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (\>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade \>=3 hematologic toxicity with the following modifications: 1) Grade \>=3 platelet count associated with bleeding, 2) Grade \>=3 absolute neutrophil count that persists for 7 or more days or th
Conditions Studied
Interventions
- DRUG enzalutamide
- DRUG fulvestrant
- DRUG anastrozole
- DRUG exemestane
Study Locations (17)
Tennessee
- The West Clinic - Germantown
- The West Clinic - Memphis
- The West Clinic - Memphis
- Tennessee Oncology, PLLC. - Nashville
- The Sarah Cannon Research Institute - Nashville
New York
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - IDS Pharmacy - New York
- Memorial Sloan Kettering Cancer Center - OPD Pharmacy - New York
- Memorial Sloan Kettering Cancer Center - New York
Colorado
- ATTN-Research Pharmacist - Aurora
- University of Colorado Cancer Center - Aurora
- University of Colorado Hospital, Anschutz Outpatient Pavilion - Aurora
Mississippi
- The West Clinic, PC - Corinth
- The West Clinic - Southaven
Connecticut
- Connecticut Multispecialty Group - Enfield
Florida
- Florida Cancer Specialists - Sarasota
Michigan
- Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2012-04-30 |
| Est. Completion | 2018-01-22 |
| Phase | Phase 1 |
What the finished NCT01597193 record still lists
NCT01597193 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which enzalutamide is the first listed.
NCT01597193 lists 17 locations in 7 states (Tennessee, New York, Colorado).
Frequently Asked Questions
What is clinical trial NCT01597193 about?
NCT01597193 is a clinical study titled "Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer". The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.
What is the current status of trial NCT01597193?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2012-04-30. Estimated completion is 2018-01-22.
What conditions does trial NCT01597193 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01597193?
The interventions under investigation include: enzalutamide (DRUG), fulvestrant (DRUG), anastrozole (DRUG), exemestane (DRUG).
Who is sponsoring clinical trial NCT01597193?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01597193 being conducted?
This trial has 17 study locations across Colorado, Connecticut, Florida, Michigan, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01597193's enrollment target sits among peer trials
101 562nd of 1224 higher than 661 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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.
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