Study on Rucaparib vs Placebo for Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03617679

Provider View

This clinical trial is testing whether Rucaparib can be an effective maintenance treatment for women with metastatic or recurrent endometrial cancer who have already undergone 1-2 previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if Rucaparib can help control metastatic or recurrent endometrial cancer after patients have completed their initial chemotherapy. Participants will be randomly assigned to receive either Rucaparib or a placebo (a non-active substance) to compare the effects. The treatment will continue until the cancer progresses, with follow-up until the end of the study.

Description

This is a Phase II clinical trial designed to test the effectiveness of Rucaparib as a maintenance therapy for women with metastatic or recurrent endometrial cancer. After completing their first line of chemotherapy, participants will be randomly divided into two groups: one group will receive Rucaparib, and the other will receive a placebo. The study aims to see if Rucaparib can help keep the cancer from progressing. Participants will continue the treatment until their cancer shows signs of progression, and they will be monitored throughout the study to assess the treatment's impact on their health and cancer progression.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 to 89 years old.
  • Diagnosed with Stage III/IV or recurrent endometrial cancer.
  • Have received at least one but no more than two previous chemotherapy treatments.
  • Completed 4 to 8 cycles of their primary chemotherapy regimen.
  • At least 4 weeks since the last chemotherapy treatment and no more than 8 weeks before starting the study treatment.
  • Completed radiation therapy to the pelvis or spine at least 4 weeks before starting the study treatment.
  • Good overall health with an ECOG performance status of 0, 1, or 2.
  • Meet specific blood test requirements, including adequate neutrophil, platelet, hemoglobin, albumin, bilirubin, AST, ALT, and creatinine levels.

Exclusion Criteria

  • Unable to follow study procedures or attend follow-up visits.
  • Have significant heart disease or recent heart attack.
  • Have serious liver disease or active hepatitis.
  • Participated in another clinical trial within the last 30 days.
  • Have chronic diseases like HIV/AIDS or hepatitis C.
  • Unable to provide informed consent.
  • Have cancer that has spread to the brain or spinal cord.
  • Have had another cancer within the last 2 years, except for certain skin cancers or breast carcinoma in situ.
  • Have had a stroke or mini-stroke in the last 3 months.
  • Have a life expectancy of less than 6 months.
  • Have not responded to recent chemotherapy.
  • Have a medical condition that makes them unfit for the trial.
  • Have a gastrointestinal condition that affects medication absorption.
  • Women who can become pregnant and do not agree to use contraception.
  • Have had recent surgery (minor within 14 days, major within 28 days) before starting treatment.

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