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Antiandrogen
Enzalutamide + Ribociclib for Prostate Cancer
Phase 1 & 2
Waitlist Available
Led By William Kevin Kelly, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of first dose until progression (25% increase in psa from nadir) or death, assessed up to 2 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of ribociclib when given with enzalutamide to see how well they work compared to enzalutamide alone in treating patients with prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of first dose until progression (25% increase in psa from nadir) or death, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of first dose until progression (25% increase in psa from nadir) or death, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicity of ribociclib (Phase IB)
Proportion of patients with a >= 50% reduction in prostate specific antigen (PSA) (Phase II)
Secondary outcome measures
Overall survival
PSA progression free survival (PFS)
Radiographic PFS (rPFS)
Other outcome measures
Androgen profiles
Proportion of patients with RB positive tumors among the screened patients by immunohistochemistry (IHC) and gene signature
Proportion of samples where RB status can successfully be obtained
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (enzalutamide, ribociclib)Experimental Treatment11 Interventions
Patients receive enzalutamide PO QD on days 1-28 and ribociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, tumor biopsy, ECHO or MUGA, bone scan, and CT or MRI on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Echocardiography
2013
Completed Phase 4
~11670
Bone Scan
2015
Completed Phase 2
~50
Enzalutamide
2014
Completed Phase 4
~2760
Ribociclib
2018
Completed Phase 3
~2330
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,865 Total Patients Enrolled
13 Trials studying Prostate Cancer
1,567 Patients Enrolled for Prostate Cancer
NovartisIndustry Sponsor
1,613 Previous Clinical Trials
2,721,222 Total Patients Enrolled
22 Trials studying Prostate Cancer
4,934 Patients Enrolled for Prostate Cancer
Prostate Cancer Clinical Trials ConsortiumOTHER
10 Previous Clinical Trials
7,192 Total Patients Enrolled
8 Trials studying Prostate Cancer
7,034 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition in your stomach or intestine that might affect how the study drug is absorbed.You have a condition affecting your brain or spinal cord, unless it meets certain criteria.You have severe peripheral neuropathy, with a score of more than 2.You cannot take any hormonal medications during the trial and must stop using them before you can participate.If you are a sexually active man, you must use a condom during sex while taking the drug and for 30 days after stopping treatment.You had radiation treatment within the past 4 weeks or limited radiation treatment for relief within the past 2 weeks.You cannot have participated in another study using an experimental medication within the past month or within 5 half-lives of that medication.You have previously taken enzalutamide or other experimental treatments targeting androgen receptors.You cannot start taking bisphosphonate or denosumab medication while participating in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (enzalutamide, ribociclib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots still available for individuals to join this experiment?
"Affirmative. According to clinicaltrials.gov, this research project is actively seeking participants after having been posted on December 1st 2015 and recently updated October 18th 2022. A total of 90 patients must be recruited from 4 study sites."
Answered by AI
How many participants are currently part of this research experiment?
"To meet the trial's requirements, 90 individuals who have passed the inclusion criteria must enroll. There are various locations available to receive treatment such as University of Michigan Comprehensive Cancer Center in Ann Arbor and Memorial Sloan Kettering Cancer Centre in New york state."
Answered by AI
Is there any prior research concerning the use of Ribociclib?
"Researched at the Rosemere Cancer Centre of Royal Preston Hospital in 2005, ribociclib has seen 115 completed trials to date. Currently 145 active clinical studies are underway and some have been conducted out of Ann Arbor, Michigan."
Answered by AI
In what therapeutic contexts is Ribociclib commonly applied?
"Ribociclib can assist in the management of malignant neoplasms, post-menopausal symptoms, and castration."
Answered by AI
Is the clinical trial being administered at multiple healthcare centers in North America?
"Currently, there are 4 sites actively recruiting patients. These include Ann Arbor, New york and Philadelphia plus 1 additional medical centre; we suggest that you opt for the closest one to reduce travel strain should you choose to join this trial."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
What site did they apply to?
University of Michigan Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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