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NCT02555189 · ClinicalTrials.gov registry record · Phase 1
Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT02555189 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 52 participants.
The verdict
NCT02555189, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This phase Ib/II trial studies the safety, side effects, best dose, and effectiveness of ribociclib when given with enzalutamide in treating patients with castrate-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naive, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Enzalutamide with ribociclib may be safe, tolerable and/or effective in treating metastatic, castrate-resistant, chemotherapy naive prostate cancer that retains retinoblastoma expression.
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Laboratory Biomarker Analysis
- DRUG Ribociclib
- DRUG Enzalutamide
- OTHER Pharmacological Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-12-01 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02555189
The ClinicalTrials.gov registry entry for NCT02555189 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02555189 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02555189 about?
NCT02555189 is a clinical study titled "Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression". This phase Ib/II trial studies the safety, side effects, best dose, and effectiveness of ribociclib when given with enzalutamide in treating patients with castrate-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic), is ch...
What is the current status of trial NCT02555189?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2015-12-01. Estimated completion is 2023-09-01.
What interventions are being tested in trial NCT02555189?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Ribociclib (DRUG), Enzalutamide (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02555189?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
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