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Tyrosine Kinase Inhibitor
Neratinib for Prostate Cancer
Phase 2
Waitlist Available
Led By David Einstein, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed metastatic prostate adenocarcinoma (secondary components of variant histology are acceptable).
Castration-resistance, with progression on medical/surgical castration and confirmed baseline testosterone <50ng/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 3 cycles through study completion, up to 24 months.
Awards & highlights
Study Summary
Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer
Eligible Conditions
- Prostate Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, every 3 cycles through study completion, up to 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 3 cycles through study completion, up to 24 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate to Neratinib
Secondary outcome measures
Best PSA response
Best Radiographic Response
Duration of Response
+3 moreSide effects data
From 2022 Phase 2 trial • 11 Patients • NCT03094052100%
Diarrhea
100%
Constipation
82%
Nausea
45%
Fatigue
45%
Abdominal distension
36%
Dizziness
36%
Headache
27%
Pruritus
27%
Weight loss
27%
Dyspnea
27%
Hot flashes
27%
Vomiting
27%
Anorexia
18%
Bloating
18%
Abdominal pain
18%
Fever
18%
Aspartate aminotransferase increased
18%
Dysgeusia
18%
Gastrointestinal disorders - Other, specify
18%
Alanine aminotransferase increased
18%
Skin and subcutaneous tissue disorders - Other, specify
18%
Sinus bradycardia
9%
Mucositis oral
9%
Infections and infestations - Other, specify
9%
Peripheral sensory neuropathy
9%
Anxiety
9%
Joint range of motion decreased
9%
Oral dysesthesia
9%
Fracture
9%
Musculoskeletal and connective tissue disorder - Other, specify
9%
Ejection fraction decreased
9%
Neck pain
9%
Cholecystitis
9%
Anal hemorrhage
9%
Chills
9%
Upper respiratory infection
9%
Vaginal infection
9%
Gastroesophageal reflux disease
9%
Lymphedema
9%
Urinary tract pain
9%
Fall
9%
Rash maculo-papular
9%
Stomach pain
9%
Pain
9%
Flatulence
9%
Back pain
9%
Vaginal hemorrhage
9%
General disorders and administration site conditions - Other, specify
9%
Paresthesia
9%
Bruising
9%
Creatinine increased
9%
Rash acneiform
9%
Wheezing
9%
Arthralgia
9%
Muscle weakness upper limb
9%
Vaginal discharge
9%
Vaginal dryness
9%
Insomnia
9%
Flu like symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Neratinib)
Trial Design
1Treatment groups
Experimental Treatment
Group I: NeratinibExperimental Treatment1 Intervention
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.
- Neratinib-once daily with 28 consecutive days defined as a treatment cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
2014
Completed Phase 2
~1970
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
835 Previous Clinical Trials
13,006,666 Total Patients Enrolled
23 Trials studying Prostate Cancer
3,754 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteOTHER
1,076 Previous Clinical Trials
340,343 Total Patients Enrolled
76 Trials studying Prostate Cancer
16,115 Patients Enrolled for Prostate Cancer
Puma Biotechnology, Inc.Industry Sponsor
56 Previous Clinical Trials
9,792 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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