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Castration-Resistant Prostate CarcinomaPhase 1/2NCT02555189

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

A Phase 1/2 study testing Enzalutamide, Ribociclib and Laboratory Biomarker Analysis in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Enzalutamide, Ribociclib and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
4 sitesUnited States
Study dates
1 Dec 2015to 1 Sep 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately; consent and HIPPA authorization must be obtained prior to any screening procedures
  • Histological or cytological proof of prostate cancer
  • Documented progressive metastatic (m)CRPC based on at least one of the following criteria:
  • PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL
  • Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions
  • Progression of bone disease (evaluable disease) or (new bone lesion[s]) by bone scan
Show all 22Show fewer
  • Have testosterone < 50 ng/dL; patients must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Patients on long term (> 6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen; patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to treatment start (no wash out period required)
  • Absolute neutrophil count >= 1.5 × 10^9/L (obtained within 14 days prior to treatment start)
  • Platelets (UNVPLT) >= 100 x 10^9/L (obtained within 14 days prior to treatment start)
  • Hemoglobin (HGB) >= 9 g/dl (obtained within 14 days prior to treatment start)
  • Potassium (K) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start)
  • Total calcium (CA) (corrected for serum albumin) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start)
  • Magnesium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start)
  • Phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start)
  • International normalized ratio (INR) =< 1.5 (obtained within 14 days prior to treatment start)
  • Serum creatinine (CREAT) =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (obtained within 14 days prior to treatment start)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN); if the patient has liver metastases, ALT and AST must still be =< 2.5 x ULN; patients with liver metastases and AST/ALT above this limit will not be enrolled (obtained within 14 days prior to treatment start)
  • Total serum bilirubin =< 1.5 x ULN; or total bilirubin (TBILI) =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's syndrome (obtained within 14 days prior to treatment start)
  • Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter
  • Must be able to take oral medication without crushing, dissolving or chewing tablets

Who cannot join

  • Prior exposure to abiraterone acetate or other specific cytochrome P450 (CYP)-17 inhibitors; abiraterone acetate given in the castration-sensitive setting is permissible if stopped at least 6 months prior to initial protocol treatment
  • Prior exposure to enzalutamide, apalutamide, or other investigational AR directed therapy
  • Prior chemotherapy for castration resistant disease; chemotherapy given in the castration-sensitive setting is permissible if stopped at least 4 weeks prior to treatment start
  • Prior isotope therapy with strontium-89, samarium or radium-223 within 12 weeks of treatment start
  • Administration of antifungal agents (itraconazole, fluconazole, etc) within 4 weeks of treatment start or unrecovered adverse events (AEs) due to agents administered more than 4 weeks of treatment start
  • History of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis or chronic liver disease
Show all 48Show fewer
  • Known symptomatic brain metastases
  • Use of any prohibited concomitant medications: immunotherapy, 5 alpha reductase inhibitors, spironolactone, diethystilbestrol (DES), ketoconazole, newer medications targeting ARs; NOTE: the concurrent use of all other drugs, over-the-counter medications, or alternative therapies must be documented; the principal investigator should be alerted if the patient is taking any agent that interacts with CYP450 system
  • Treatment-related toxicity from prior therapy > grade 2
  • Peripheral neuropathy >= 2
  • History of hypersensitivity to ribociclib or compounds of similar chemical or biologic composition to ribociclib including to peanut and soy or other drugs formulated with polysorbate 80; or enzalutamide
  • Currently taking any herbal, alternative or food supplements (i.e., prostate cancer [PC]-Spes, saw palmetto, St John wort, etc.); all herbal, alternative and food supplements must be discontinued prior to treatment start; patients may continue on a daily multi-vitamin, calcium and vitamin D
  • Planned surgery or radiation therapy during protocol treatment
  • Hormonal-acting agents (including DES, aldosterone, and spironolactone but not including gonadotropin-releasing hormone [GnRH] agonists or antagonists) are forbidden during the trial and must be stopped prior to treatment start; no washout period will be required for any of these agents
  • Initiation of bisphosphonate/denosumab therapy during protocol treatment; patients on stable doses of bisphosphonates or denosumab which have been started no less than 4 weeks prior to treatment start may continue on this medication; NOTE: initiation of bisphosphonate/denosumab therapy will be allowed for the treatment of osteoporosis or prevention of skeletal-related events (SRE) during protocol treatment
  • Patient has a concurrent malignancy or malignancy within 3 years of treatment start, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patient has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory)
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
  • Patient has clinically significant, uncontrolled heart disease and/or recent events including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to treatment start
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Documented cardiomyopathy
  • Patient has a left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening
  • History of any cardiac arrhythmias, eg., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months prior to treatment start
  • Family history of corrected QT interval (QTc) prolongation or of unexplainable sudden death at < 50 years of age
  • On screening 12 lead electrocardiogram (ECG), any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or Fridericia corrected QT (QTcF) > 450 msec; congenital long QT syndrome or family history of long QT syndrome
  • Systolic blood pressure (SBP) > 160 mmHg or < 90 mmHg
  • Bradycardia (heart rate < 50 at rest), by ECG or pulse, at screening
  • On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia's correction); all as determined by screening ECG (mean of triplicate ECGs)
  • Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to treatment start:
  • Known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 4 (5), including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges
  • That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
  • That have a known risk to prolong the QT interval or induce Torsades de Pointes
  • Herbal preparations/medications, dietary supplements
  • Patient is currently receiving or has received systemic corticosteroids within < 2 weeks prior to treatment start, or who have not fully recovered from side effects of such treatment
  • The following uses of corticosteroids are permitted: a short duration (< 5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
  • Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
  • PatientParticipation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational product (whichever is longer) or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. If the patient is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the Novartis study medical lead is required to establish eligibility
  • Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to treatment start, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 30% of the bone marrow was irradiated
  • Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
  • At least 4 weeks from prior therapy completion (including radiation and/or surgery) to treatment start
  • Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases
  • Patient has had major surgery within 14 days prior to treatment start or has not recovered from major side effects (tumor biopsy is not considered as major surgery)
  • Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with grade 1 taxane-induced neuropathy, any grade of alopecia, amenorrhea or other toxicities not considered a safety risk for the patient as per investigator's discretion, are allowed to enter the study)
  • Patient with a Child-Pugh score B or C
  • Patient has a history of non-compliance to medical regimen or inability to grant consent
  • Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period; a condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • 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

Other trials in United States

About this study

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose of ribociclib in combination with 160 mg of enzalutamide. (Phase Ib) II. To determine efficacy with respect to the proportion of subjects that achieve a >= 50% reduction in prostate-specific antigen (PSA) at 12 weeks. (Phase II)

SECONDARY OBJECTIVES:

  1. PSA progression-free survival. II. Radiographic progression-free survival (rPFS). III. Safety. IV. Pharmacokinetics.

CORRELATIVE/EXPLORATORY/TERTIARY OBJECTIVES:

  1. To evaluate the expression of retinoblastoma (RB) in circulating tumor cells (CTCs) and tumor tissue.

II. To evaluate other mechanisms of castrate resistance (such as androgen receptor [AR]-variant [v]7) in tumor tissue and CTCs.

III. To explore resistance mechanisms of cyclin dependent kinase (CDK)4/6 inhibitors in tumor samples in patients that progress on enzalutamide and ribociclib.

IV. Explore the use/correlation of circulating deoxyribonucleic acid (DNA)/exosomes in castrate-resistant prostate cancer (CRPC) patients treated with enzalutamide with and without ribociclib.

  1. Androgen profiles and correlation to clinical outcomes. VI. Development of model explant systems to correlate with the clinical outcome.

OUTLINE: This is a phase I, dose-escalation study of ribociclib followed by a phase II study.

Patients receive enzalutamide orally (PO) once daily (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, echocardiography (ECHO) or multigated acquisition scan (MUGA), bone scan, and computed tomography (CT) or magnetic resonance imaging (MRI) on study.

After completion of study treatment, patients are followed up every 3 months for 24 months.

Being tested
Enzalutamide, Ribociclib, Laboratory Biomarker Analysis, Pharmacological Study, Biospecimen Collection
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called Xtandi, MDV3100, 915087-33-1, ASP9785

    Given PO

  • RibociclibDrug

    Also called LEE011, 1211441-98-3, 7-Cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide, Kisqali

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, MUGA

    Undergo MUGA

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

Study groups in NCT02555189
Study groupRoleWhat they receive
Phase I: 200 mg Ribociclib + EnzalutamideExperimentalEnzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily. 200 mg Ribociclib will be given daily for 21 out of 28 days. The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
Receives: Drug: Enzalutamide; Drug: Ribociclib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Phase I: 400 mg Ribociclib + EnzalutamideExperimentalEnzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily. 400 mg Ribociclib will be given daily for 21 out of 28 days. The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
Receives: Drug: Enzalutamide; Drug: Ribociclib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Phase I: 600 mg Ribociclib + EnzalutamideExperimentalEnzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily. 600 mg Ribociclib will be given daily for 21 out of 28 days. The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
Receives: Drug: Enzalutamide; Drug: Ribociclib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Phase II: Enzalutamide OnlyActive comparatorPatients receive Enzalutamide 160mg PO QD once daily on Days 1-28 of each 28-day cycle. This is one of two randomized arms in the Phase II portion. Treatment continues until disease progression or unacceptable toxicity. Patients also undergo blood sample collection, tumor biopsy, ECHO or MUGA, bone scan, and CT or MRI on study.
Receives: Drug: Enzalutamide; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Ribociclib at RP2D + EnzalutamideExperimentalPatients receive Ribociclib 600mg PO QD once daily on Days 1-21 of each 28-day cycle in combination with Enzalutamide 160mg PO QD once daily. This is one of two randomized arms in the Phase II portion. Patients will continue treatment until disease progression or unacceptable toxicity. Patients also undergo blood sample collection, tumor biopsy, ECHO or MUGA, bone scan, and CT or MRI on study.
Receives: Drug: Enzalutamide; Drug: Ribociclib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Dose Limiting Toxicity of Ribociclib (Phase IB)

    Will be defined as an adverse event or clinically significant abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications. All analysis will be descriptive.

    Measured: 28 days

  2. Number of Patients With a >= 50% Reduction in Prostate Specific Antigen (PSA) (Phase II)

    The primary objective for the phase II component of this study is to determine efficacy with respect to the proportion of subjects that achieve a ≥ 50% reduction in PSA at 12 weeks.

    Measured: 12 weeks

Secondary outcomes (3)

  1. PSA Progression Free Survival (PFS)

    Summarized by treatment arm using Kaplan-Meier plots. Median PFS will be estimated from the Kaplan-Meier analysis.

    Measured: Time of first dose until progression (25% increase in PSA from nadir) or death, assessed up to 2 years

  2. Radiographic PFS (rPFS)

    Summarized using Kaplan-Meier plots. Median rPFS will be estimated from the Kaplan-Meier analysis.

    Measured: From first dose to disease progression in bone or soft-tissue, or death, whichever occurs first, assessed up to 40 months

  3. Overall Survival

    To determine the overall safety and survival for patients treated with enzalutamide with and without ribociclib in patients with chemotherapy naïve mCRPC.

    Measured: From first dose until death from any cause, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2015 (estimated)
  2. Study start1 Dec 2015
  3. Primary completion7 Dec 2022
  4. Study completion1 Sep 2023

Why it stopped: Sponsor-PI decision. An analysis of the primary endpoint concluded that the addition of ribociclib to standard of care enzalutamide did not demonstrate benefit, an all active subjects were removed from the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02555189
Sponsor's protocol ID
15G.322
Other IDs
CLEE011XUS12T, c15-153, JT 7786
Status last verified
Mar 2026
First submitted
14 Sep 2015
Last updated
22 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Enzalutamide, Ribociclib and Laboratory Biomarker Analysis in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Dose Limiting Toxicity of Ribociclib (Phase IB) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02555189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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