Senaparib (IMP4297) 20 mg for mCRPC

Phase-Based Estimates
1
Effectiveness
2
Safety
Princess Alexandra Hospital, Brisbane, Australia
Eligibility
18+
Male
Eligible conditions
mCRPC

Study Summary

Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Senaparib (IMP4297) 20 mg will improve 16 secondary outcomes in patients with mCRPC. Measurement will happen over the course of 80 weeks.

80 weeks
Cmax
ORR according to RECIST v1.1 assessed by the investigator
OS
Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
Objective response rate (ORR) according to RECIST v1.1 assessed by investigator
PFS2
PSA response rate according to PCWG3 criteria assessed by central laboratory
PSA response rate according to PCWG3 criteria assessed by local laboratory
Safety endpoints
Time from randomization to the first SSRE
Time to PSA progression
Time to pain progression
plasma PK profile
rPFS assessed by BICR
rPFS assessed by the investigator
rPFS in BRCA1, BRCA2 or ATM mutation positive patients assessed by BICR. Mutation positive indicates deleterious or suspected deleterious mutation.

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Placebo
Senaparib (IMP4297) 20 mg
Placebo group

This trial requires 285 total participants across 2 different treatment groups

This trial involves 2 different treatments. Senaparib (IMP4297) 20 Mg is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Senaparib (IMP4297) 20 mg
Drug
During the treatment period, eligible patients will receive single agent of Senaparib at a dose of 100 mg once daily (QD), continuously on a 4-week cycle
Placebo
Drug
During the treatment period, eligible patients will receive placebo QD, continuously on a 4-week cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 80 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 80 weeks for reporting.

Closest Location

Our lady of Lourdes Urology - Binghamton, NY

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The study participants must agree to participate in the study willingly and must sign a written informed consent form prior to any study activity. show original
Male patients must use a condom during treatment, and for 3 months after the last dose of study drug, when they have sexual intercourse with a woman who could become pregnant show original
Patients must have a confirmed diagnosis of prostate cancer given by a pathologist. show original
Someone who has had their testicles surgically or medically removed, and who has serum testosterone levels of ≤50 ng/dL (≤1.73 nmol/L) is eligible for the study show original
Patients have normal organ functions, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), and other relevant medical support within 14 days before the administration of study drug). show original
A man aged 18 or over can sign the ICF. show original
To have an ECOG performance status of 0 to 2 means that you are a cancer patient who is able to carry out normal activities and who has only some minor symptoms. 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 mcrpc?

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In contrast to classical bacterial infections, the mechanisms that cause mcrpc are not clear. However, the results suggest the presence of some bacteria (such as "Pseudomonas aeruginosa", "Serratia marcescens", "Xylella fastidiosa", "Wolinella succinogenes", and "Serratia marmarica"), fungal infections, or certain types of bacterial toxins and/or viruses might be the cause or at least play a factor in it.

Unverified Answer

What is mcrpc?

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The MCRPC is a multidrug resistant strain of Pseudomonas aeruginosa. It was found that the antibiotic resistance genes of the mcr-1, aac(6′)II, and fip/foe had been transferred into the chromosomal backbone of mdtA of P. aeruginosa PAO1. Therefore, gene transfer might have occurred by plasmid transfer. The development of mcr-1, aac(6′)II, and fip/foe has been described in China. At present, all strains of P. aeruginosa tested have this antibiotic resistance gene.

Unverified Answer

What are common treatments for mcrpc?

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For most patients with mcrpc, the disease is successfully controlled with antibacterial or antifungal agents. Some cases are intrinsically refractory to standard antibacterial or antifungal agents. In these cases, there are many potential drug regimens for which further study is needed.

Unverified Answer

How many people get mcrpc a year in the United States?

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About 3.7 percent, or 1.3 million children in the U.S. will have one positive diagnosis at some point in time. Many people have two or more diagnoses. The number of conditions that cause disability is enormous.

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What are the signs of mcrpc?

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Mycobacterial infection is suspected when the patient presents a febrile illness with or without other signs and symptoms, although only about half of the cases are due to mcrpc. The isolation of M. tuberculosis and a positive tuberculin test do not necessarily imply infection with M. bovis due to mcdpc, but may simply represent a false-positive result as a consequence of vaccination. The isolation of mb from the blood test, in combination with symptoms such as a chest X-ray, may be useful in pointing to the diagnosis of a mcdpc.

Unverified Answer

Can mcrpc be cured?

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Data from a recent study suggests that this treatment is not curative. However, patients with very severe phenotype showed some degree of recovery after the initial cycle. This finding is worth bearing in mind when considering future strategies of targeted treatment for patients with severe MPCM.

Unverified Answer

Have there been any new discoveries for treating mcrpc?

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We [have] [not] [identified any new mcrpc-specific therapies] [or treatments]. In our view, the most important [research on mcrpc] is the investigation of possible targets for treatment. We [and the other investigators] shall be very [determined] to continue to search the scientific literature, take advantage of recently developed genetic tests, and keep up [a] constant contact with [research in progress] [and new treatment ideas].

Unverified Answer

Does mcrpc run in families?

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Although the penetrance for mcrpc in non-families was high, the prevalence of Mcrpc in families was comparable with non-familial cases. Therefore, MCRPC does not appear on the list for 'familial' conditions.

Unverified Answer

What are the common side effects of senaparib (imp4297) 20 mg?

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The common side effects of 20 mg of senaparib are fatigue, nausea, and upper respiratory tract infections. No deaths were reported for any of the studied phases of the study.

Unverified Answer

Has senaparib (imp4297) 20 mg proven to be more effective than a placebo?

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Results from a recent paper of this study have not demonstrated superiority for the treatment of patients with recurrent platinum-sensitive or platinum-resistant ovarian cancer with the addition of 20 mg senaparib to carboplatin relative to carboplatin alone.

Unverified Answer

What is the primary cause of mcrpc?

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The incidence of mcrpc continues to rise and remain the leading cause of treatment failure. Clinicians should be alert for the increasing prevalence of this condition and the difficulty in managing it. To increase the rates at which the disease is treated, clinicians should discuss these findings with their patients and take precautionary measures to decrease the spread of infection through body fluids during contact with the environment. With the development of a vaccine, the incidence and mortality rate associated with mcrpc will likely decrease.

Unverified Answer

What are the latest developments in senaparib (imp4297) 20 mg for therapeutic use?

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This is the first phase 3 study to assess its efficacy and safety profile in metastatic breast cancer (mBC) patients with acquired somatic BRCA mutations. PFS was prolonged in the population of patients with BRCA mutations, confirming the activity of Imparza. This is the first clinical experience with a non-BRCA mutation-targeted therapeutic agent in mBC. This Phase 3 study is the first to assess the safety profile of the combination of Imparza and irinotecan and supports the potential benefit of the combination therapy in this patient population.

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