In short
Clinical trials are investigating Rucaparib in several cancer settings, mainly ovarian, fallopian tube, and primary peritoneal cancer, as well as some broader solid tumor studies. These trials look at how well it works, how safe it is, and whether it helps in maintenance treatment or in combination with other cancer drugs.
Key points
- Clinical trials of Rucaparib are mainly studying ovarian, Fallopian tube, and primary peritoneal cancers, with one broader study in several advanced cancer types. The trial data includes Phase 2 and Phase 3 research, plus a Phase 1 dose-finding part in one ovarian cancer study. Some studies test Rucaparib alone, while others test it with medicines such as bevacizumab or nivolumab. The main goals are to measure safety, tumor response, and progression-free survival, which is the time before the cancer gets worse. Several trials also focus on people whose cancer has specific features, such as HRD status, or on patients who already responded to first-line platinum-based chemotherapy.
Clinical trial overview
The trial data shows that Rucaparib is being studied in both focused and broader cancer trials. Most of the studies are in ovarian cancer and related cancers, but one large study also includes other advanced cancers such as multiple myeloma and non-Hodgkin lymphoma. The studies are mostly interventional, which means people receive a study treatment and the research team measures the results.
Ovarian and related cancer studies
One Phase 2 study, MITO 25.1, is testing treatment choices in advanced stage III B-C-IV ovarian, primary peritoneal, and Fallopian tube cancer. This study compares treatment groups that include carboplatin, paclitaxel, bevacizumab, and Rucaparib, and it is guided by HRD status, which means the tumor’s ability to repair DNA is used to help choose treatment. The trial also includes an earlier Phase 1 part to find the Maximum Tolerated Dose, the highest dose that does not cause too many serious side effects.
Another Phase 3 study is looking at Rucaparib as maintenance treatment after a response to front-line platinum-based chemotherapy in advanced ovarian epithelial, malignant peritoneal, high-grade epithelial ovarian, Fallopian tube, or primary peritoneal cancer. In this study, maintenance treatment means treatment given after the first successful therapy to help keep the cancer from returning or growing. The study compares Rucaparib alone, Rucaparib with nivolumab, and placebo groups, so it is testing both the single drug and a combination approach.
A separate Phase 2 trial in recurrent ovarian cancer also includes Rucaparib in its intervention list, together with other cancer medicines such as carboplatin and other treatments used in ovarian cancer research. This study focuses on patients with FRα high disease who are eligible for platinum-based chemotherapy, meaning the tumor has a high level of folate receptor alpha and the patient can receive platinum treatment. Its main endpoint is progression-free survival, which measures how long people live without the cancer getting worse.
Broader cancer study
The DRUP trial is a large Phase 2 study with many targeted cancer drugs, including Rucaparib. It includes people with advanced solid tumors, non-Hodgkin lymphoma, T-cell prolymphocytic leukemia, and multiple myeloma. The study aims to see whether treatment can be matched to a patient’s molecular tumor profile, which means the study looks at the tumor’s genetic or protein changes to guide therapy.
This trial also looks at whether the treatment has anti-tumor activity and what toxicities occur with targeted drugs used in real-world cancer care. It is a very large study, with an enrollment of 3000 participants.
Main endpoints and what they mean
The trials measure different endpoints, which are the main results the researchers want to learn from the study.
- Progression-free survival (PFS): This is the time from randomization or treatment start until the cancer gets worse or the patient dies.
- Objective tumor response: This shows whether tumors shrink after treatment.
- Disease control: In the DRUP study, this includes stable disease at 16 weeks after treatment starts, meaning the cancer has not clearly grown at that time point.
- Maximum Tolerated Dose: In the Phase 1 part of MITO 25.1, this is the highest dose that can be given without too many dose-limiting toxicities, which are side effects that stop the dose from being increased safely.
- Adverse events: These are unwanted medical problems during treatment. The DRUP study measures treatment-related grade 3 or higher events, serious adverse events, and deaths.
Who can participate
Who can join depends on the trial and the cancer type.
- People with advanced stage III B-C-IV ovarian, primary peritoneal, or Fallopian tube cancer may be eligible for the MITO 25.1 study.
- People with advanced solid tumors, multiple myeloma, non-Hodgkin lymphoma, or T-cell prolymphocytic leukemia may be eligible for the DRUP trial if their tumor has a matching molecular feature.
- People with recurrent ovarian cancer who are eligible for platinum-based chemotherapy may be eligible for the Phase 2 study of Mirvetuximab soravtansine, which also lists Rucaparib among the study drugs.
- People with advanced ovarian epithelial, malignant peritoneal, high-grade epithelial ovarian, Fallopian tube, or primary peritoneal cancer who responded to first-line platinum-based chemotherapy may be eligible for the Phase 3 maintenance study.
Trial phases and study designs
The trial data includes Phase 2 and Phase 3 studies, with one study that starts with a Phase 1 dose-escalation part.
Phase 1 focuses on dose finding, while Phase 2 and Phase 3 focus more on how well treatment works and how safe it is in larger groups.
Several studies are randomized, which means participants are assigned by chance to different treatment groups so the results can be compared fairly.