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Also known as Niraparib Tosylate Monohydrate
Niraparib · 1 trial · 1 indication
This is a dose-escalation study of niraparib plus abemaciclib followed by an efficacy study for late-line treatment of ovarian cancer
Maximum tolerated dose (MTD) of niraparib in combination with abemaciclib in patients with advanced ovarian cancer defined as the dose level immediately below the dose at which ≥ 33% of patients experience dose-limiting toxicity as defined by protocol according to CTCAE 5.0
proportion of patients whose disease shrinks (i.e. complete or partial response) or remains stable over 16 weeks after the start of niraparib + abemaciclib combination. Revised RECIST 1.1 criteria will be used to assess tumor response
| Arm | Type | Description |
|---|---|---|
| ARM 1 | EXPERIMENTAL | Niraparib+Abemaciclib |
| Name | Type | Description |
|---|---|---|
| Niraparib Tosylate Monohydrate | DRUG | Combination of niraparib and abemaciclib |
Inclusion Criteria: * Has read and understands the informed consent form and has given written informed consent prior to any study procedures. * Age \> 18 years * Life expectancy of at least 3 months * Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer * Confi...
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Niraparib is an investigational small molecule being studied for the treatment of ovarian cancer. It is currently in Phase 1 clinical development as a late-line treatment option, meaning it is being evaluated for patients who have already received prior therapies. The drug is being tested in combination with another agent in a clinical trial.
Niraparib targets PARP, a class of enzymes involved in DNA repair. By inhibiting PARP, the drug is designed to interfere with cancer cells' ability to repair DNA damage, potentially leading to cell death. This mechanism is being explored in the context of ovarian cancer treatment.
Niraparib is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with ovarian cancer.
Niraparib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness. The current trial is actively recruiting participants.
Niraparib is being studied in a Phase 1 clinical trial with the identifier NCT06594679. The trial, titled 'A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)', is recruiting 73 female participants aged 18 years and older in Italy.
Yes, Niraparib is also known as Niraparib Tosylate Monohydrate. These names refer to the same drug substance, with the full chemical name often used in pharmaceutical contexts. The drug is being developed by Eli Lilly and Company for the treatment of ovarian cancer.