Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

NCT03617679 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 18-0567.ccP30CA046934
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Endometrial Cancer

Keywords

Rucaparib; Placebo; Randomized; Double Blind; Stage III/IV

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression free survival is defined as cycle 1 day 1 (C1D1) till the time of progression as determined by RECIST 1.1 criteria or death.

  Up to 48 months.

Secondary Outcomes (2)

• Overall Survival (OS)

  Up to 48 months.

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 48 months.

Study Arms (2)

Active Ingredient

ACTIVE COMPARATOR

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

Drug: Rucaparib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Rucaparib 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.

Active Ingredient

Placebo Oral Tablet 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be a female aged 18-89.
• Patients with a primary Stage III/IV or recurrent endometrial cancer.
• Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).
• Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.
• Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Absolute neutrophil count (ANC) \> or = 1500 cells/microliters
• Platelet count \> 100,000 microliters
• Hemoglobin \> or = 9.0 g/dL
• Serum albumin \> or = 2.5 g/dL
• Total bilirubin ≤ 1.5 x ULN (uppler limit of normal)

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Inability to comply with study and follow-up procedures
• 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
• 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
• Participation in investigational clinical trial within last 30 days
• History of significant chronic disease including HIV/AIDS or hepatitis C
• Inability to provide informed consent
• Known central nervous system (CNS) malignancy or CNS metastases
• 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.
• History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1)
• Women with prognosis for survival less than 6 months
• Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen
• Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion
• Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication
• Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Clovis Oncology, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 40700852 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

rucaparib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Bradley Robert Corr, MD
• Organization: University of Colorado Denver

bradley.corr@cuanschutz.edu

303-724-2066

Study Officials

• Bradley Corr, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active ingredient vs placebo

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 6, 2018
• Study Start: March 6, 2019
• Primary Completion: October 31, 2023
• Study Completion: February 27, 2026
• Last Updated: March 24, 2026
• Results First Posted: July 1, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)