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.
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.
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.
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.
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.
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.
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.
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.
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].
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.
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.
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.
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.
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.