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Rucaparib

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.

Table of Contents

Clinical trial overview

The trial data shows that Rucaparib is being studied in both focused and broader cancer trials.[1][4] 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.[2] The studies are mostly interventional, which means people receive a study treatment and the research team measures the results.[1][5]

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.[1] 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.[1] 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.[1]

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.[5] In this study, maintenance treatment means treatment given after the first successful therapy to help keep the cancer from returning or growing.[5] The study compares Rucaparib alone, Rucaparib with nivolumab, and placebo groups, so it is testing both the single drug and a combination approach.[5]

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.[3] 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.[3] Its main endpoint is progression-free survival, which measures how long people live without the cancer getting worse.[3]

Broader cancer study

The DRUP trial is a large Phase 2 study with many targeted cancer drugs, including Rucaparib.[2] It includes people with advanced solid tumors, non-Hodgkin lymphoma, T-cell prolymphocytic leukemia, and multiple myeloma.[2] 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.[2]

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.[2] It is a very large study, with an enrollment of 3000 participants.[2]

Main endpoints and what they mean

The trials measure different endpoints, which are the main results the researchers want to learn from the study.[1][2][3][5]

  • Progression-free survival (PFS): This is the time from randomization or treatment start until the cancer gets worse or the patient dies.[1][3][5]

  • Objective tumor response: This shows whether tumors shrink after treatment.[2]

  • 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.[2]

  • 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.[1]

  • 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.[2]

Who can participate

Who can join depends on the trial and the cancer type.[1][2][3][5]

  • People with advanced stage III B-C-IV ovarian, primary peritoneal, or Fallopian tube cancer may be eligible for the MITO 25.1 study.[1]

  • 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.[2]

  • 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.[3]

  • 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.[5]

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.[1][2][3][5]

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.[1][2][5]

Several studies are randomized, which means participants are assigned by chance to different treatment groups so the results can be compared fairly.[1][3][5]

Trial ID Phase Condition studied Status Enrollment
2024-516632-99-00 Phase 2 Advanced ovarian, primary peritoneal, and Fallopian tube cancer Authorised 300
NCT02925234 Phase 2 Advanced solid tumor, non-Hodgkin lymphoma, T-cell prolymphocytic leukemia, multiple myeloma Authorised 3000
NCT04274426 Phase 2 Recurrent ovarian cancer eligible for platinum-based chemotherapy Authorised 136
NCT03899155 Phase 2 Pan tumor Authorised 588
2024-516662-11-00 Phase 3 Advanced ovarian epithelial, malignant peritoneal, high-grade epithelial ovarian, Fallopian tube, or primary peritoneal cancer after response to front-line platinum-based chemotherapy Authorised 1000

FAQ

  • What is being studied in Rucaparib trials? The trials study Rucaparib alone or with other cancer medicines. Main goals include checking treatment benefit, safety, and how long cancer stays under control.
  • Who can join these trials? Eligibility depends on the study. Some trials include people with advanced ovarian, fallopian tube, or primary peritoneal cancer, while others include patients with advanced solid tumors or other cancers.
  • What trial phases are shown? The trial data includes Phase 2 and Phase 3 studies, plus one study with a Phase 1 dose-escalation part before the Phase 2 part. Phase 1 finds a safe dose, while later phases test how well treatment works.
  • What outcomes do the trials measure? Common outcomes include progression-free survival, which means the time before the cancer grows or the patient dies, and objective tumor response, which means how many tumors shrink.
  • Are the trials only for ovarian cancer? No. Several trials focus on ovarian and related cancers, but one trial also includes advanced solid tumors, non-Hodgkin lymphoma, T-cell prolymphocytic leukemia, and multiple myeloma.

Ongoing Clinical Trials on Rucaparib

  • Study on the Effectiveness of Entrectinib and Other Drug Combinations for Patients with Advanced Solid Tumors, Multiple Myeloma, or Non-Hodgkin Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Long-term Safety of Nivolumab and Drug Combination for Cancer Patients from Previous BMS Trials

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +4

  • Study on Mirvetuximab Soravtansine and Carboplatin for Patients with Recurrent Ovarian Cancer Eligible for Platinum-Based Chemotherapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Rucaparib and Nivolumab for Maintenance Treatment in Patients with Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer After Chemotherapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark Germany Greece Ireland +5

  • Study on Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib for Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Patients

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Advanced cancer: Cancer that has spread further in the body or is at a later stage.
  • Ovarian cancer: Cancer that starts in the ovary, which is part of the female reproductive system.
  • Fallopian tube cancer: Cancer that starts in the tubes that connect the ovaries to the uterus.
  • Primary peritoneal cancer: Cancer that starts in the lining of the abdomen and can look very similar to ovarian cancer.
  • Phase 1: An early trial phase that checks dose and finds the highest dose people can take safely.
  • Phase 2: A trial phase that looks more closely at whether a treatment works and continues to check safety.
  • Phase 3: A larger trial phase that compares treatments in more people.
  • Progression-free survival (PFS): The length of time during and after treatment that the cancer does not get worse.
  • RECIST: A standard way doctors use scans to measure whether tumors shrink, stay the same, or grow.
  • Homologous Recombination Deficient (HRD): A tumor feature that means the cancer has a problem repairing DNA; some trials use this to choose treatment groups.
  • Maintenance treatment: Treatment given after the cancer first responds, to help keep it from coming back or growing.
  • Randomization: A method that puts participants into different treatment groups by chance.

References