Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

NCT ID: NCT03617679

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2025-12-31

Brief Summary

This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.

Detailed Description

This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.

Conditions

Metastatic Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Ingredient

1:1 Randomization. Participants in this arm receive the active ingredient medication.

Group Type: ACTIVE_COMPARATOR

Rucaparib

Intervention Type: DRUG

Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.

Placebo

1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.

Interventions

Rucaparib

Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.

Intervention Type: DRUG

Placebo Oral Tablet

Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision to sign and date the consent form.

2. Stated willingness to comply with all study procedures and be available for the duration of the study.

3. Be a female aged 18-89.

4. Patients with a primary Stage III/IV or recurrent endometrial cancer.

5. Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).

6. Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.

7. Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.

8. Patients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

10. Absolute neutrophil count (ANC) > or = 1500 cells/microliters

11. Platelet count > 100,000 microliters

12. Hemoglobin > or = 9.0 g/dL

13. Serum albumin > or = 2.5 g/dL

14. Total bilirubin ≤ 1.5 x ULN (uppler limit of normal)

15. AST and ALT ≤ 3.0 x ULN

16. Serum Creatinine ≤ 1.5x ULN

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Inability to comply with study and follow-up procedures

2. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina

3. Known clinically significant liver disease defined as AST and ALT > 3.0 x ULN and/or Total bilirubin > or = 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease

4. Participation in investigational clinical trial within last 30 days

5. History of significant chronic disease including HIV/AIDS or hepatitis C

6. Inability to provide informed consent

7. Known central nervous system (CNS) malignancy or CNS metastases

8. Patients with previous malignancy, other than endometrial, within the past 2 years from cycle 1, day 1, with the exception of those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast.

9. History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1)

10. Women with prognosis for survival less than 6 months

11. Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen

12. Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion

13. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication

14. Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing

15. Minor surgical procedure < or = 14 days or major surgeries < or = 28 days prior to first dose of treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clovis Oncology, Inc.

INDUSTRY

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley Corr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

References

Corr BR, Haggerty A, Gysler SM, Taylor S, Behbakht K, Alldredge J, Lefkowits C, Brubaker LW, Bouts C, Babayan LM, Martin LP, Costello J, Bitler BG, Hu J, Guntupalli SR. A phase II, randomized, double-blind study of the use of rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer. Gynecol Oncol. 2025 Sep;200:58-67. doi: 10.1016/j.ygyno.2025.07.008. Epub 2025 Jul 22.

Reference Type: DERIVED

PMID: 40700852 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-0567.cc

Identifier Type: -

Identifier Source: org_study_id