Study on Niraparib Maintenance Therapy for Uterine Serous Carcinoma

Sponsor: Northwell Health

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04080284

Provider View

This clinical trial is exploring the effectiveness and safety of using Niraparib as a maintenance treatment for patients with advanced or recurrent uterine serous carcinoma, a type of endometrial cancer. The study aims to see if Niraparib can help control the cancer and improve patient outcomes.

Patient Parameters

Program Overview

Uterine serous carcinoma (USC) is a serious form of endometrial cancer that accounts for a significant number of deaths related to this disease. It shares many characteristics with serous ovarian cancer, including certain genetic mutations. This study is testing Niraparib, a medication that may help maintain cancer control in patients with advanced or recurrent USC that is sensitive to platinum-based chemotherapy. Researchers believe that Niraparib will be well-tolerated and effective in reducing cancer progression in these patients.

Description

Uterine serous carcinoma (USC) is a less common but more aggressive type of endometrial cancer, often diagnosed at an advanced stage. It shares similarities with ovarian cancer, including genetic mutations that affect DNA repair. This study focuses on using Niraparib, a PARP inhibitor, as a maintenance treatment to help control USC after initial chemotherapy. PARP inhibitors work by targeting cancer cells with specific DNA repair deficiencies, potentially leading to better outcomes for patients.

Niraparib has shown promise in treating ovarian cancer, and this trial aims to see if it can similarly benefit patients with USC. The study will evaluate how well Niraparib works in maintaining cancer control and its safety profile. Participants will receive Niraparib after completing their chemotherapy regimen, and their health and cancer progression will be closely monitored.

The trial is based on the understanding that USC shares genetic and clinical features with other cancers that respond to PARP inhibitors. By targeting these shared characteristics, Niraparib may offer a new treatment option for patients with advanced or recurrent USC.

Eligibility Criteria

Inclusion Criteria

  • Female, aged 18 years or older.
  • Good overall health with an ECOG performance status of less than 2.
  • Willing to provide written informed consent.
  • Diagnosed with uterine serous carcinoma (USC).
  • Agree to undergo specific genetic testing (Foundation One testing).
  • Have advanced stage USC (stage III, IV) or recurrent USC that is sensitive to platinum-based chemotherapy.
  • If the cancer has returned, it must have responded to initial treatment and progressed more than 6 months after the last platinum chemotherapy.
  • Eligible if receiving first or second line chemotherapy for recurrence.
  • Must have shown a partial, stable, or complete response to the last chemotherapy regimen.
  • Must start Niraparib maintenance within 12 weeks after the last chemotherapy dose, or within 14 weeks if radiation was received.
  • Tumors can be measurable or non-measurable by standard criteria.
  • Adequate organ function, including specific blood cell counts and liver and kidney function.
  • Stable corticosteroid use for at least 4 weeks before starting the study.
  • Agree not to donate blood during the study and for 90 days after the last dose.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Agree not to breastfeed during the study and for 180 days after the last dose.
  • Able to take oral medications.

Exclusion Criteria

  • Currently enrolled in another interventional clinical trial.
  • Recent drainage of fluid buildup (ascites) during the last two chemotherapy cycles.
  • Recent radiation therapy affecting a large portion of bone marrow or any radiation within one week before starting the study.
  • Persistent severe anemia, low white blood cell, or platelet counts from previous cancer treatment.
  • Uncontrolled brain or spinal fluid metastases.
  • Allergic to Niraparib components.
  • Major surgery within three weeks before starting the study or not fully recovered from surgery.
  • Recent diagnosis or treatment of another invasive cancer within two years, except for certain skin cancers.
  • Considered a poor medical risk due to serious, uncontrolled medical conditions or infections.
  • Recent blood transfusion or use of growth factors to boost blood cell counts.
  • History of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Immunocompromised patients, except those who have had a spleen removed.
  • Active hepatitis infection.
  • Previous treatment with a PARP inhibitor.
  • High mutational burden in specific genetic markers (MSI-H).

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