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
- Hormone Refractory Prostate Cancer
- Prostate Cancer Metastatic to Bone
- Hormone-Refractory Prostate Cancer
- Advanced Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: Time of first dose until progression (25% increase in PSA from nadir) or death, assessed up to 2 years
12 weeks
Proportion of patients with a >= 50% reduction in PSA (Phase II)
28 days
Dose limiting toxicity of Ribociclib (Phase IB)
Year 2
Radiographic PFS (rPFS)
Year 2
PSA progression free survival (PFS)
Up to 2 years
Overall survival
Trial Safety
Safety Progress
Side Effects for
Ribociclib + Fulvestrant
55%Neutropenia
45%Nausea
31%Fatigue
29%Diarrhoea
26%Vomiting
24%Constipation
24%Arthralgia
22%Headache
22%Cough
20%Pruritus
19%Alopecia
18%Rash
18%Neutrophil count decreased
17%Back pain
16%Anaemia
16%Leukopenia
16%Decreased appetite
14%Asthenia
14%Alanine aminotransferase increased
14%Dyspnoea
13%Pain in extremity
13%Hot flush
13%Aspartate aminotransferase increased
12%White blood cell count decreased
12%Oedema peripheral
12%Dizziness
12%Insomnia
11%Nasopharyngitis
10%Stomatitis
10%Abdominal pain upper
10%Dyspepsia
10%Pyrexia
10%Urinary tract infection
10%Hypertension
9%Upper respiratory tract infection
8%Dry skin
8%Myalgia
8%Musculoskeletal pain
8%Bone pain
7%Abdominal pain
7%Blood creatinine increased
7%Gamma-glutamyltransferase increased
7%Dysgeusia
7%Muscle spasms
6%Electrocardiogram QT prolonged
6%Neck pain
6%Oropharyngeal pain
6%Anxiety
6%Depression
5%Thrombocytopenia
5%Influenza like illness
5%Dry mouth
3%Musculoskeletal chest pain
2%Pneumonia
1%Acute kidney injury
1%Dehydration
1%Pleural effusion
1%Pneumothorax
1%Pulmonary embolism
1%Febrile neutropenia
1%Non-cardiac chest pain
1%Hip fracture
Trial Design
2 Treatment Groups
Enzalutamide
1 of 2
Enzalutamide + Ribociclib
1 of 2
Experimental Treatment
90 Total Participants · 2 Treatment Groups
Primary Treatment: Ribociclib · No Placebo Group · Phase 1 & 2
Enzalutamide
Drug
Experimental Group · 1 Intervention: Enzalutamide · Intervention Types: DrugEnzalutamide + RibociclibExperimental Group · 2 Interventions: Enzalutamide, Ribociclib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved
Ribociclib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time of first dose until progression (25% increase in psa from nadir) or death, assessed up to 2 years
Who is running the clinical trial?
Prostate Cancer Clinical Trials ConsortiumOTHER
10 Previous Clinical Trials
7,138 Total Patients Enrolled
NovartisIndustry Sponsor
1,586 Previous Clinical Trials
2,702,697 Total Patients Enrolled
1 Trials studying Hormone Refractory Prostate Cancer
28 Patients Enrolled for Hormone Refractory Prostate Cancer
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
11,755 Total Patients Enrolled
William Kevin Kelly, MDPrincipal InvestigatorThomas Jefferson University
Eligibility Criteria
Age 18+ · Male Participants · 10 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments