Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

ClinicalTrials.gov ID: NCT02555189

Public ClinicalTrials.gov record NCT02555189. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Phase IB/II Study of Enzalutamide With Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Naïve Prostate Cancer That Retains RB Expression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02555189
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University; Other
Enrollment: 52 participants

Conditions and interventions

Conditions

Interventions

Drug · Other · Procedure

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 30, 2015
Primary completion: Dec 6, 2022
Completion: Aug 31, 2023
Last update posted: Apr 21, 2026

2015 – 2023

United States locations

U.S. sites: 4
U.S. states: 3
U.S. cities: 4

Facility	City	State	ZIP	Site status
University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	48109	—
Roswell Park Cancer Institute	Buffalo	New York	14263	—
Memorial Sloan Kettering Cancer Center	New York	New York	10065	—
Thomas Jefferson University	Philadelphia	Pennsylvania	19107	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02555189, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 21, 2026 · Synced Sep 9, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02555189 live on ClinicalTrials.gov.

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