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NCT01553188 · ClinicalTrials.gov registry record · Phase 2
AMG 386 and Abiraterone for Advanced Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01553188: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01553188 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01553188, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
Background: * Advanced prostate cancer is treated with surgery or drugs that lower the levels of androgens (male hormones) in the body. However, some cancers become resistant to this treatment. These types of cancers are known as castration-resistant prostate cancers. * Interfering with the growth of blood vessels that feed tumors can slow prostate cancer growth. Trebananib (AMG 386), a new anticancer drug, targets the blood vessels that feed tumors. It has been tested for different types of cancer, but not for prostate cancer. Researchers want to see if AMG 386 can slow disease progression in men with castration-resistant prostate cancer. AMG 386 will be given with abiraterone and prednisone, two drugs that are also used to treat advanced prostate cancer. Objectives: \- To test the safety and effectiveness of AMG 386 with abiraterone for castration-resistant prostate cancer. Eligibility: \- Men at least 18 years of age with castration-resistant prostate cancer. Design: * Participants will be screened with a physical exam, medical history, and imaging studies. Blood and urine samples will also be collected. * Participants will be separated into two groups. * The first group will have AMG 386 once per week for a total of four doses during a 28-day cycle. They will also take abiraterone once a day and prednisone twice a day, every day of the cycle. * The second group will not have AMG 386. They will take abiraterone once a day and prednisone twice a day, every day of the 28-day cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the study drugs as long as the disease does not progress and there are no severe side effects.
Interventions
- DRUG Prednisone
- DRUG Abiraterone
- DRUG AMG 386
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-02-08 |
| Est. Completion | 2018-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01553188
The ClinicalTrials.gov registry entry for NCT01553188 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01553188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01553188 about?
NCT01553188 is a clinical study titled "AMG 386 and Abiraterone for Advanced Prostate Cancer". Background: * Advanced prostate cancer is treated with surgery or drugs that lower the levels of androgens (male hormones) in the body. However, some cancers become resistant to this treatment. These types of cancers are known as castration-resistant prostate cancers. * Interfering with the growth ...
What is the current status of trial NCT01553188?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2012-02-08. Estimated completion is 2018-07-01.
What interventions are being tested in trial NCT01553188?
The interventions under investigation include: Prednisone (DRUG), Abiraterone (DRUG), AMG 386 (DRUG).
Who is sponsoring clinical trial NCT01553188?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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