Neratinib for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Dana-Farber Cancer Center, Boston, MA
Prostate Cancer+5 More
Neratinib - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms
  • Adenocarcinoma
  • Castration-resistant Prostate Cancer
  • Metastatic Prostate Adenocarcinoma
  • refractory, metastatic hormone-refractory Prostate cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Neratinib will improve 1 primary outcome and 6 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 84 days.

24 Months
Best PSA response
Progression Free Survival
6 Months
Overall Survival
84 days
Response Rate to Neratinib
Month 24
Best Radiographic Response
Duration of Response
Month 24
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Side Effects for

N240 + C2000
Diarrhoea
100%
Decreased appetite
75%
Palmar-plantar erythrodysaesthesia syndrome
75%
Vomiting
50%
Asthenia
50%
Nausea
50%
Weight increased
25%
Accidental overdose
25%
Lymphopenia
25%
Hypercholesterolaemia
25%
Fatigue
25%
Muscular weakness
25%
Lacrimation increased
25%
Mucosal inflammation
25%
Lip dry
25%
Upper respiratory tract infection
25%
Blood alkaline phosphatase increased
25%
Rhinorrhoea
25%
Skin lesion
25%
Anxiety
25%
Nail dystrophy
25%
Activated partial thromboplastin time prolonged
25%
Weight decreased
25%
Onycholysis
25%
Oedema peripheral
25%
Nail infection
25%
Cough
25%
Thrombocytopenia
25%
Pyrexia
25%
Candida infection
25%
Contusion
25%
Alanine aminotransferase increased
25%
Aspartate aminotransferase increased
25%
Gamma-glutamyltransferase increased
25%
Hyperglycaemia
25%
Hypomagnesaemia
25%
Pigmentation disorder
25%
Posture abnormal
0%
Early satiety
0%
Hypoaesthesia
0%
Dyspnoea
0%
Dry skin
0%
Hyperbilirubinaemia
0%
Disease progression
0%
Blood alkaline phosphatase abnormal
0%
General physical health deterioration
0%
Proctitis
0%
Calculus ureteric
0%
Shock haemorrhagic
0%
Skin infection
0%
Night sweats
0%
Gastroenteritis viral
0%
Dermatitis
0%
Melaena
0%
Femur fracture
0%
Hypokalaemia
0%
Lacunar infarction
0%
Hypotension
0%
Thrombosis
0%
Ascites
0%
Cystitis
0%
Acarodermatitis
0%
Ataxia
0%
Ligament sprain
0%
Blood glucose increased
0%
Arthralgia
0%
Back pain
0%
Pain in extremity
0%
Dizziness
0%
Dysarthria
0%
Neuralgia
0%
Depression
0%
Insomnia
0%
Breast swelling
0%
Haematuria
0%
Epistaxis
0%
Nail disorder
0%
Arteriosclerosis
0%
Lymphoedema
0%
Skin fissures
0%
Anaemia
0%
Febrile neutropenia
0%
Pericardial effusion
0%
Leukopenia
0%
Influenza like illness
0%
Paronychia
0%
Wound infection pseudomonas
0%
Hypoglycaemia
0%
Onychoclasis
0%
Vertigo
0%
Pain
0%
Dehydration
0%
Dental caries
0%
Small intestinal obstruction
0%
Abdominal discomfort
0%
Blood lactate dehydrogenase increased
0%
Hyperphosphataemia
0%
Somnolence
0%
Metrorrhagia
0%
Hyperhidrosis
0%
Tachycardia
0%
Abdominal pain
0%
Breast pain
0%
Hypothyroidism
0%
Cheilitis
0%
Dry mouth
0%
Stomatitis
0%
Xerosis
0%
Convulsion
0%
Oedema
0%
Seasonal allergy
0%
Fall
0%
Blood bilirubin increased
0%
Musculoskeletal chest pain
0%
Dysgeusia
0%
Dysuria
0%
Haemorrhage
0%
Blood creatinine increased
0%
Sinus congestion
0%
Spinal cord compression
0%
Abdominal distension
0%
Chills
0%
Face injury
0%
Nervous system disorder
0%
Renal failure
0%
Hypersensitivity
0%
Pulmonary embolism
0%
Breast neoplasm
0%
Dyspepsia
0%
Inflammation
0%
Gastroenteritis
0%
Respiratory tract infection
0%
Urinary tract infection
0%
Radius fracture
0%
Electrocardiogram QT prolonged
0%
Liver function test abnormal
0%
Muscle spasms
0%
Headache
0%
Neurotoxicity
0%
Productive cough
0%
Haematemesis
0%
Pneumonia
0%
Herpes zoster
0%
Ureteric stenosis
0%
Nerve root compression
0%
Hypoxia
0%
Respiratory failure
0%
Neutropenia
0%
Abdominal pain upper
0%
Constipation
0%
Faeces soft
0%
Gastrointestinal disorder
0%
Mouth ulceration
0%
Intestinal obstruction
0%
Impaired healing
0%
Implant site pain
0%
Injection site extravasation
0%
Lobar pneumonia
0%
Nasopharyngitis
0%
Rhinitis
0%
Periorbital contusion
0%
Haemoglobin decreased
0%
International normalised ratio increased
0%
Hyponatraemia
0%
Musculoskeletal pain
0%
Neck pain
0%
Myalgia
0%
Balance disorder
0%
Monoparesis
0%
Neuropathy peripheral
0%
Peripheral sensory neuropathy
0%
Alopecia
0%
Rash
0%
Hypertension
0%
Biloma
0%
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT00741260) in the N240 + C2000 ARM group. Side effects include: Diarrhoea with 100%, Decreased appetite with 75%, Palmar-plantar erythrodysaesthesia syndrome with 75%, Vomiting with 50%, Asthenia with 50%.

Trial Design

2 Treatment Groups

Control
Neratinib

This trial requires 14 total participants across 2 different treatment groups

This trial involves 2 different treatments. Neratinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Neratinib
Drug
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
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, every 3 cycles through study completion, up to 24 months.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, every 3 cycles through study completion, up to 24 months. for reporting.

Who is running the study

Principal Investigator
D. J. E.
David J. Einstein, MD
Dana-Farber Cancer Institute

Closest Location

Dana-Farber Cancer Center - Boston, MA

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, is required Castration therapy with either a prior orchiectomy or ongoing gonadotropin releasing hormone (GnRH) agonist/antagonist therapy is required. show original
Patients must have progressed on one androgen-receptor inhibitor and must have no limits to prior therapies. show original
The patient must have a positive biomarker (phospho human epidermal growth factor receptor 2, pHER2) assessment on baseline tissue show original
The text says that a baseline PSA level of 2.0 ng/mL or higher is considered high. show original
The text is about a measureable disease show original
The ability to understand and willingness to sign an informed consent form are both necessary for someone to participate in a study. show original
The study participant is willing to have a research biopsy if needed, and will also provide a biopsy sample at baseline if necessary for biomarker assessment. show original
during cancer care Anti-resorptive therapy, such as denosumab or bisphosphonates, can be used at any stage of cancer care. show original
A prostate cancer that has spread to other parts of the body and can be identified through a microscope. show original
, is an acceptable therapeutic endpoint for appropriate patients with prostate cancer show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes prostate cancer?

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The cause of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) remains currently unknown. Risk factors appear to include age, ethnicity, a family history of the disease, high prostate-specific antigen (PSA) levels, and exposure to radiation. The role of genetics remains unclear. Recent advances in molecular and cellular biology suggest a possible pathogenic mechanism whereby alterations in the DNA repair machinery lead to the accumulation of mutations and thus an increased likelihood of developing prostatic tumours.

Unverified Answer

Can prostate cancer be cured?

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The cure rate for cancers of the prostate is extremely high, while the cure rate for cancers of other sites is significantly lower. However, the vast majority of men do not have evidence of overt metastases or circulating tumors during follow-up after definitive therapy. Therefore, the possibility that cancers may spontaneously regress cannot be excluded. If spontaneous remission is possible, it does not change the high cure rate; in some studies, more than 90% of men were obviously cured of both prostate and of any cancer. Men at high risk of developing prostate cancer, and of whose disease we have good evidence of complete and persistent treatment compliance, can be cured. When surgery can be successful in removing the benign prostate gland, a cure certainly is possible.

Unverified Answer

What are common treatments for prostate cancer?

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The treatments of prostate cancer in this population are very complex. The standard of care for a prostate cancer patient involves radiotherapy and hormonal therapy. These modalities are often preceded by surgery and, rarely, local ablative therapies. The most common and the most expensive treatments involve radiation or androgen deprivation. The treatment most frequently offered to these patients is brachytherapy. On the other hand, treatment modalities are frequently changed on the basis of patients' response to treatments. Given that such treatments can be costly, complex, and sometimes with significant side effects, the current reimbursement for their use is variable across the United States. Furthermore, many patients are not provided with all of the above-mentioned treatment modalities in a single institution.

Unverified Answer

What is prostate cancer?

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The majority of the men have had their prostate removed by prostatectomy. The pathology report typically contains the diagnosis of BPH or PCa, but is vague regarding whether it is localized or organ-confined disease. A biopsy that contains cancer has a probability of approximately 50 to 60%. Only 25% of the patients were diagnosed while still asymptomatic (60<or = PSA<10 ng/ml) – these cases may represent the most curable cases. The prostate tumour may be localised to the prostate but also metastasised to other organs and/or the lymph nodes. Only 15% are bilateral and only 3% have a low grade Gleason Score, i.e.

Unverified Answer

What are the signs of prostate cancer?

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Recent findings suggest that:  (1) elevated prostate specific antigen is a reliable indicator of prostate cancer and will provide a means of early detection, (2) serum digital rectal examination allows accurate detection of prostate cancer, and (3) clinical staging provides valuable information about prostate cancer.

Unverified Answer

How many people get prostate cancer a year in the United States?

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In a recent study, findings suggests that it is time to begin to collect the national data needed to confirm our findings that a significant proportion of patients are diagnosed with clinically localized prostate cancer. This knowledge will give an insight to the use of imaging to diagnose prostate cancer earlier and improve outcomes.

Unverified Answer

How quickly does prostate cancer spread?

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Patients with a cT grade 3 or 4 prostate cancer have a low likelihood of nodal metastasis following RP. Tumor location remains the most significant predictor of nodal metastases following RP.

Unverified Answer

Has neratinib proven to be more effective than a placebo?

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Neratinib demonstrated a significantly greater than placebo effect and was well tolerated over an extension phase I/III study, with more patients progressing to the next phase and having higher rates of progressive disease. Data from a recent study are consistent with our Phase II data and confirms the clinical effectiveness of RT+neratinib in patients with early stage or'slow growing' NSCLC.

Unverified Answer

Does prostate cancer run in families?

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Given the frequent co-existence of BPH and [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in both spouses of patients carrying and of patients with prostate cancer, and a strong association with relatives in prostate cancer, we suggest that a BPH/prostate cancer co-adoption model can be a powerful concept to explain this relationship.

Unverified Answer

What are the common side effects of neratinib?

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Neratinib has proven to be safe in the treatment of adult patients with metastatic disease. Side effects encountered in this population have included fatigue, dyspnea, nausea, pain, and diarrhea. The majority of patients discontinued treatment due to either pain or fatigue, however, the most common side effect was abnormal liver function. Neratinib has not been found to significantly worsen the condition of patients who previously received cisplatin-based chemotherapy.

Unverified Answer

Does neratinib improve quality of life for those with prostate cancer?

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Treatment of patients with advanced or metastatic prostate cancer with neratinib resulted in improved QOL compared to placebo among patients having been previously treated for this disease.

Unverified Answer

What is the latest research for prostate cancer?

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This article offers the latest research on prostate cancer to help physicians and patients to understand and diagnose this disease. It also helps us to select the most appropriate treatment options, which is crucial in reducing the likelihood of suffering prostate cancer-related deaths.

Unverified Answer
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